Communication between Sponsor and FDA – Best Practices

Communication between Sponsor and FDA – Best Practices

By Mary Waters

Anyone who deals with the FDA should become familiar with the FDA Guidance for Industry and Review Staff Best Practices for Communication Between IND Sponsors and FDA During Drug Development. This Guidance represents FDA’s current thinking on the topic; its purpose is to describe some best practices and procedures for timely and effective communications between Sponsors and the FDA.

With the 2012 Prescription Drug User Fee Amendments (PDUFA) ACT, the FDA agreed to develop a dedicated drug development communication and training staff. Within CBER, CDER, and MATTB (Manufacturers Assistance and Technical Training Branch) their focus was to enhance the communications between the FDA and Sponsors during product development. Both CBER and CBER agreed to jointly publish this Guidance for industry and FDA review staff, gathered review staff’s suggested best practices, and incorporated input from interested parties to create this Guidance.

FDA Terms to Remember

Shall, must, required: These words or terms convey a statute or regulatory requirement.

Advisable, should, critical, may be appropriate, discourage, encourage, prefer, recommend, suggest, urge: These words or terms mean that something is suggested or recommended, but not required.

Guidance: Not legally enforceable, represent Agency’s current thinking, viewed only as recommendations unless specific regulatory or statutory requirements are cited.

FDA Regulatory Project Managers (FDA RPMs): Collectively, review division RPMs and specific functional area RPMs are referred to as FDA RPMs.

Regulatory Project Managers (RPMs): These RPMs oversee projects, processes, and programs; primary contacts for facilitating timely resolution of technical, scientific, and regulatory questions, issues, or other challenges between Sponsors and review teams.

Review Division RPMs: Primary point of contact for communications between Sponsor and FDA during drug development life cycle.

Do’s and Don’ts

• Do obtain authorization from your Sponsor (in writing) if you are an independent consultant before initiating contact with the FDA.

• Do reach out to the next level supervisor (division chief or branch chief) if Sponsor encounters challenges in obtaining feedback.

• Do establish a mutually agreeable communication strategy early in the relationship. FDA suggests a preferred method(s) (email vs telephone) and frequency of communications, and/or how to manage information requests (singularly or bundled; daily or weekly).

• Do not contact the FDA reviewers, team leaders, and senior management directly; instead, direct inquiries to the assigned FDA RPM which ensures Sponsor requests are communicated to review team members.

• Do not delay in responding to FDA information requests as this can negatively affect later development.

Types of Advice that Sponsors Seek

FDA policy positions are typically documented in FDA Guidance’s, MAPPS (Manuals of Policies and Procedures), and SOPPs (Standard Operating Procedures and Policies). These topics include:

  • Regulatory
  • Clinical
  • Safety
  • Clinical pharmacology / pharmacokinetics
  • Nonclinical pharmacology, pharmacokinetics, and toxicology
  • Product quality
  • Pediatric

The FDA has stated that complex scientific or technical drug development questions should be directed to the FDA RPMs via either a submission or through the formal meeting request process.

Note, however, the FDA has also stated that their resources are limited, and strongly encourage Sponsors to seek answers first from other resources; or employ an independent consultant for assistance. Using this approach allows for resource conservation involving more complex and/or challenging issues.

General Expectations of Communications

The FDA realizes that timely and effective communication during the IND phase of drug development gives Sponsors information they need to help design studies/trials, in addition to product quality data intended to support future approval of a marketing application.

Note: Safety-related questions will be prioritized higher than routine inquiries.

Sponsors should realize that questions posed as simple or needing clarifying can sometimes be more than “routine”. When questions turn out to be complex and require significant review before an answer can be provided, they end up demanding significant resources and response time. The FDA suggests that these types of questions be posed in more formal situations (meetings/submissions).

Meetings can be formal between the FDA and Sponsors, such as face-to-face, teleconference, or with written response only (WRO). The FDA has written feedback timelines outlined in the PDUFA and BsUFA, as well as the FDA meeting guidances. Feedback from the FDA include preliminary comments, final meeting minutes, and questions posed in the WRO request.

Submissions made to an IND during its life cycle may involve hundreds of supporting documents which could require variable degrees of review for which communication is needed with the Sponsor. Other submissions have regulatory-mandated timelines (e.g. safety-related submissions) or drug development submissions without a regulatory clock but are critical and may require a new protocol or a protocol amendment. In these instances, communications between the FDA and Sponsor is critical.

Other inquiries received via telephone, email or through a submission without a specific timeline which ask specific questions, the FDA RPM will attempt to acknowledge the communication within three (3) business days of receipt via telephone or email. The acknowledgment will include:

The response within the acknowledgment time frame;

  • The estimated time frame for division response to question(s);
  • If questions will involve consultation with other parties, for example, policy questions where legal input is necessary;
  • Recommendations to submit a formal meeting request; or
  • Recommend Sponsor contact another functional area in the FDA.

Sponsors will need to acknowledge receipt of FDA’s request either in writing or in other ways and provide to the FDA RPM an estimated response time.

Best Practices FDA Buzz Words

  • Shall, must, require or requirement – these words convey a statutory or regulatory requirement
  • Advisable, critical, important, may be appropriate should consider, discourage, encourage, prefer, recommend, suggest or urge – these words or phrases convey advice, comments, or current FDA thinking.

Communication Methods

Since the IND phase of drug development is typically a multiyear process, the FDA recognizes that new data will become available as well as new scientific and regulatory advances changes in clinical practice over time.

There are a number of ways to communicate with the FDA and this Guidance provides in-depth descriptions on each method.

References

The FDA website contains two pages that provide information for industry:

  1. a) The FDA Basics for Industry web page can be found here:
  2. b) Investigator-Initiated Investigational New Drug (IND) Applications web page includes links to information for investigators about submitting INDs to FDA and can be found here:

Take Away

HartmannWillner is well versed in communicating with the FDA. In fact, we have completed hundreds of communications with FDA RPMs. If you need advice on how to write a question or want to set up a meeting, we are here to make that happen. Please contact us.

Mary is an expert provider of electronic Common Technical Documents  (eCTD) publishing services. Since joining HW in 2016, Mary has submitted over 225 electronic submissions through the FDA ESG.

HW was at FDA for the Part 15 public hearing

HW was at FDA for the Part 15 public hearing

By Nitisha Pyndiah, PhD

HW reports

HW was at FDA for the Part 15 public hearing on facilitating competition and innovation in the biological products marketplace

 On September 4, 2018, FDA held a public hearing to hear comments from different stakeholders on FDA’s Biosimilar Action Plan (BAP).

HW was there and reports. This meeting was a great opportunity to listen to patients and patient advocacy groups express their concerns and reminding us all, why we work in the field. Industry leaders and physicians also talked about the gaps that they identified, and innovator drug manufacturers presented arguments against biosimilars.  

A major discussion topic was about interchangeable products; patient advocacy group explained their concerns over patients having to switch to different biosimilars after being stable on a treatment thus highlighting the need to increase patients and healthcare providers education about biosimilars. Speakers expressed their views on the changes that they would like to see including those to the purple book. Of no surprise, originator product developers questioned the safety of switching from one biosimilar to another, but FDA responded promptly and clarified that the risk was similar or greater when switching within the same drug class or when the originator drug manufacturer makes manufacturing changes, which is common practice. There were also still discussions about the use of random suffixes for non-proprietary names and the fact that they could mislead when it comes to pharmacovigilance and also make biosimilars look inferior to the reference product. Overall, an interesting meeting where participants called for “real-life data” on biosimilars. Commissioner Gottlieb intervened to express FDA’s strong support to biosimilar developers in an aim to reduce the high cost of biologics. He emphasized on the fact that he was not satisfied of the current state of biologics market and that half of the biosimilars approved are not on the market. Commissioner Gottlieb did mention that FDA was working with the Federal Trade Commission (FTC) to work on the gamic tactics to delay competition. Certain participants asked if FDA could collaborate with the US Patent and Trademark Office to resolve intellectual property issues related to originators preventing biosimilars to enter the marketplace. One of the features of the BAP is FDA’s initiative to reduce gaming of FDA requirements by working with legislators to close loopholes.

In this blog post, I propose to list FDA’s BAP key actions and discuss items covered during the Part 15 hearing:

“Developing and implementing new FDA review tools such as standardized review templates”

“Creating information resources and development tools for sponsors of biosimilar applications”

“Enhancing the purple book to include more information about approved biological products”

Most speakers commented on their wish to see the purple book improved. The Biosimilar Forum and an originator company explained that a new column to designate biosimilars or interchangeable products should be added for clarification purpose. The Biosimilar Forum also noted that adding the date of exclusivity expiration would be very useful to sponsors. An industry representative added that manufacturing changes such as the number and types of changes should be added to the purple book. Other speakers also expressed their wish to have patent information listed in the purple book such as in the orange book.

“Actively exploring the potential for entering into new data sharing agreements with foreign regulators to facilitate the increased use of non-US licensed comparator products in certain studies to support a biosimilar application”

A company on the biosimilar side, spoke about using non-US comparators for interchangeables, and, a nonprofit organization, spoke about using non-US comparators if FDA multinational data shows that they are within acceptable FDA ranges. FDA was also urged to define analytical requirements for non-US reference product, no more no less.

“Establishing a new Office of Therapeutic Biologics and Biosimilars (OTBB) to improve coordination and support of activities under the BsUFA program”

FDA already established the Therapeutic Biologics and Biosimilars Staff (TBBS) under the Office of New Drugs (OND) to coordinate with other offices at CDER to ensure consistent review. FDA is now in the process of transferring TBBS to the new OTBB. This transition will allow to improve coordination, accelerate response time to the different stakeholder and support policy development.

“Building on the FDA’s Biosimilar Education and Outreach Campaign”

Patient advocacy groups explained that they wanted to understand better how a biological product is biosimilar. They wish to understand the analytical characterization better.

Some mentioned that they needed education when the patient goes to the physician practice as not all patients will educate themselves online.

This week, FDA published a useful resource to help explain the biosimilar development process and the data required to demonstrate biosimilarity. Link

“Publishing final or revised draft guidance on biosimilar product labeling to assist sponsors in determining what data and information should be included in the labeling”

“Providing additional clarity for product developers on demonstrating interchangeability, including by publishing final or revised draft guidance”

Several stakeholders mentioned their concerns about interchangeability, mainly, patient advocacy groups explained that they do not wish for the pharmacist to change the treatment for an interchangeable product without approval of the physician or the patient specially when the patient is finally stable on a treatment after series of complications.

Industry representatives recommended to include the scope of interchangeability designations in product labeling. An industry representative recommended clarifying the guidance on interchangeability, including information on changes in formulation. Several industry speakers pushed for the inclusion of non-US comparator for interchangeables.

“Providing additional clarity and flexibility for product developers on analytical approaches to evaluating product structure and function to support a demonstration of biosimilarity”

“Providing additional support for product developers regarding product quality and manufacturing process, including by identifying physical product quality attributes that are most critical to evaluate, and by exploring ways to reduce the number of lots of the reference product required for testing”

 

HW experts can help you with the development of your biosimilar, we are on the forefront of biosimilar policies and regulations we’ve been developing biosimilars for 16 years – and can assist you from early to late stages whether it is to advise regarding your analytical and functional studies, your non clinical studies, your clinical studies, your manufacturing process, your IND and BLA preparation or to submit your regulatory submissions to FDA. HW can also assist you with any FDA communications and prepare your materials for meetings.

 

Nitisha Pyndiah - Biotech Consulting Services

Nitisha Pyndiah, PhD, is a Consultant where she provides advice for the development of biological, biotechnological, and biosimilar products.

Nitisha provides expertise in the areas of virology, molecular biology, microbiology, immunology, immunogenicity, quality control, GLP andGMP. She prepares and evaluates CMC sections, including FDA meeting documents; and conducts scientific and regulatory gap analyses. She supports technical, strategic, and operational regulatory affairs for recombinant proteins, monoclonal antibodies, and vaccines.

 

Hyperlinks

Hyperlinks

By Mary Waters, Senior Consultant, eCTD Publish Services

Noun; a link from a hypertext file or document to another location or file, typically activated by clicking on a highlighted word (typically blue colored text) or an image on the screen. There is a method to the madness and thought processes associated with the blue colored text for hyperlinks. You can read more about the history of hyperlinks and how the blue text was selected in the Hyperlink Usability: Guidelines for Usable Links (Naji, 2016).

Hyperlink(s) is(are) a reference point to data that the reader can directly follow by clicking, tapping, or hovering. A hyperlink can point to a whole document or just to a specific part within a document.

Hypertext is text with hyperlinks. The text, that is linked from is called the anchor text.

Both internal and external links allow users of the website to navigate to another web page or resource. Users can navigate from one resource to another by clicking on hyperlinks. Internal links help users navigate the same website, whereas external links generally take users to a different webpage or website.

In the eCTD world, there are a few rules that make reviewing documents easier and therefore, with less trouble for your FDA Reviewer. In most submissions, your FDA Reviewer will find many hyperlinks. Here are some best practices that apply to hyperlinks and how to use or apply them in your documents.

  1. Standard practice as per US, EU or other country guidelines typically link to the first reference on the page; and does not link for duplicates found on the page (you would only link the first one on that page as the reviewer can use that link over and over). As with cross-references and destinations located on the same page, you don’t have to link those two together.
  2. For every link in your document, when pointing to or from the same or different document, these links do need to be checked – each one needs to work properly!
  3. Using designated “styles” for your headings, tables and figure captions with the Microsoft Word “insert cross-reference” tool will facilitate the publishing process. When using this tool, the references are automatically updated as your document changes, and hyperlinks are automatically created when you convert to PDF. Tip: be sure to create the heading, table, page number, etc. before creating the link.
  4. Links could be generated automatically using Word PDF Maker or Adobe Pro for internal links and automatically linked in the publishing tool for external links.
  5. Links need to be obvious; reviewers do not want to interact with the interface to find the links.
  6. Pick or create a hyperlink design (style) and make it consistent throughout all of your documents (e.g. font name, Calibri; size 12 pt; colors R-0, G-0, B-255; update the hyperlink style to reflect changes and make the changes default).
  7. It’s helpful for links to change colors after they have been clicked (changing from blue to purple). This helps the reviewer to know when a link has been used.
  8. To emphasizes that the links are clickable, make sure the style changes with mouse-overs.
  9. Don’t use “click here” for the hyperlink text; reword so that the linked word(s) match the title of the destination (paragraph, page, form, etc.)

Hyperlinks and Validation Errors

Listed below are a few of the hyperlink validation errors that might be returned with improperly applied hyperlinks. Some of these links are more problematic than others (high, medium, low). It’s best practice to fix every one that you can before submitting through the ESG.

Broken Hyperlink (number 5200, medium): Documents with one or more hyperlinks pointing to a file that does not exist.

Non-existent Named Destination or Page (number 5202, medium): This is a document with one or more hyperlinks pointing to a “named” destination or page that does not exist.

Corrupt Link (number 5201, medium): One or more documents pointing to a file that cannot be opened.

Multiple Action Hyperlink (number 5203, medium): Links that contain one or more (multiple) actions.

External Hyperlink (number 5205, medium): Web references in a hyperlink (web links, email links); external but do not open in “new window”.

Inactive Hyperlink (number 5210, medium): Document that has one or more inactive links that are functioning.

Non-relative Hyperlink (number 5215, medium): Document that has one or more non-relative (absolute) hyperlinks.

 

If you’re still having issues with your hyperlinks, let us help you validate them. We’re just an email or phone call away.

References

Hyperlink Usability: Guidelines for Usable Links https://usabilitygeek.com/hyperlink-usability-guidelines-usable-links/

Wikipedia: https://en.wikipedia.org/wiki/Hyperlink

US FDA, eCTD Validation Criteria

 

 

Nitisha Pyndiah - Biotech Consulting Services

Mary is an expert provider of electronic Common Technical Documents (eCTD) publishing services. Since joining HW in 2016, Mary has submitted over 225 electronic submissions through the FDA ESG.

 

Biosimilar Marketing Application CMC Deficiencies identified in the US and in Europe

Biosimilar Marketing Application CMC Deficiencies identified in the US and in Europe

By Nitisha Pyndiah, PhD

Regulatory agencies such as FDA and EMA require that biosimilars be highly similar and have no clinically meaningful differences with a reference product. In February 2018, EMA published in AAPS PharmSciTech, trends in deficiencies identified during the evaluation of the quality part of applications for marketing authorizations. Several of these deficiencies have also been observed in the US.

Here I propose to discuss common deficiencies that I found in biosimilar applications and use the list of common quality deficiencies in EMA marketing submission as a basis. By doing so, I wish to help biosimilar developers address or avoid deficiencies prior to submission to allow their product to reach market faster!

Part 1: What are the major deficiencies identified regarding the Drug Substance?

Biocomparability: Issues due to lack of supporting data when comparing reference product to proposed biosimilar. Differences in glycosylation not well elucidated, insufficient data regarding differences in potency assay results.

Analytical methods validation: All validation characteristics recommended for the type of test should be done. All validation data should be submitted to the regulatory body. I have often seen that there was insufficient validation of the analytical method used.

Reference standards or materials: Issues with calibration and qualification, lack of information about in-house reference material and how they were established.

Stability: Inadequate or insufficient stability data to support the proposed shelf life. No appropriate stability results using the proposed container closure system.

Processes: The manufacturing process and process controls should be described thoroughly.

Specifications: The lack of justification regarding the specification of DS. Specifications unmet due to insufficient validation of the analytical method used.

Drug substance comparability: Comparability of similar manufacturing processes not adequately shown.

Sourcing of reference product: To obtain licensure a sponsor has to demonstrate that the proposed product is biosimilar to a reference product that has been previously licensed by FDA or establish an acceptable bridge between the non-US reference product the US-licensed reference product and the biosimilar.

I have often seen sponsors using a non-US product prior to using a US-licensed reference product and carrying out bridging studies. Inconsistencies in the sourcing of the reference product for the comparability program for quality, safety and efficacy studies have been seen.

Characterization: A common deficiency is the inadequate elucidation of structure and characteristics of the DS, I have observed that the elucidation of the structure was often incomplete. Orthogonal physicochemical methods are important in confirming the structure and characteristics of the drug substance. FDA strongly recommends using multi-parameter approaches that are extremely sensitive in identifying analytical differences.

Mainly, I have often seen that glycosylation was not well characterized; differences in post translational modifications (PTM) between the reference product and the biosimilar may lead to immunogenicity (i.e detrimental immune response in the patients commonly measured using anti-drug antibodies). The most common PTM is glycosylation and should be well characterized to also ensure that not clinically meaningful differences are observed between a biosimilar and a reference product. The drug substance is produced in nonhuman tissues, therefore it is important to ensure that nonhuman glycosylation that could potentially induce a detrimental immune response are not present.

Do you need help with your biosimilar product?

Are you in the process of developing a biosimilar biological product? Do you need help preparing and submitting your IND or BLA to the FDA? Or perhaps you need to request a Biosimilar Initial Advisory Meeting or a Biosimilar Product Development (BPD) Meeting. We can help. Contact us today to learn more about our services and how we can help you advance our product with the FDA

 

 

Nitisha Pyndiah - Biotech Consulting Services

Nitisha Pyndiah, PhD, is a Consultant where she provides advice for the development of biological, biotechnological, and biosimilar products.

Nitisha provides expertise in the areas of virology, molecular biology, microbiology, immunology, immunogenicity, quality control, GLP andGMP. She prepares and evaluates CMC sections, including FDA meeting documents; and conducts scientific and regulatory gap analyses. She supports technical, strategic, and operational regulatory affairs for recombinant proteins, monoclonal antibodies, and vaccines.

 

Biosimilar developer, what are your BsUFA fees for FY 2019? Let’s clarify those for you!

Biosimilar developer, what are your BsUFA fees for FY 2019? Let’s clarify those for you!

By Nitisha Pyndiah, Ph.D.

 

The BPD/Program Fee invoices for FY2019 were emailed on August 27, 2018. As a follow-up to my previous blog post on the BsUFA II fees, I will list the BsUFA fees since FY 2015 and use two case studies to help you understand the changes in your Biosimilar User Fees.

In our previous blog post, we described the user fee types for biosimilars: Biosimilar Biological Product Development (BPD) Fees, Application fees and Program fees. We highlighted a major change which eliminated the reduction of an application fee by the cumulative amount of fees paid by the applicant under the BPD program. For certain biosimilar developers that have been in the program for a long time it means an important budget change as there would be no deduction to their application fees. This increase in the fees will be used to expedite the review process for biosimilars, enhance review transparency and communication. According to the Agency, in the BsUFA II Five-year Financial Plan: “During BsUFA I, FDA received fewer original biosimilar biological product application submissions than the Agency had initially expected to receive, which resulted in the collection of relatively more BPD fees than expected and fewer application, establishment, and product fees […] FDA anticipates that many of the development programs started in BsUFA I will convert to original submissions early in BsUFA II, which would contribute to an increase in application review work relative to BsUFA I.”

As a biosimilar developer, you should be aware of these changes to plan appropriately your drug development and maybe realign your budget.

To understand better the change in fees, the user type fees from FY2015 to FY2019, have been listed in the table below.

In green, no reduction on the application fee.

Table 1: Overview of the BsUFA fees from FY 2015 to FY 2019.

Case Study 1

In June 2017, a company A submitted their BLA for their Biosimilar product. Company A had been in the program for three years and would have paid $ 891,660 in BPD fees ($ 216,910 initial BPD fees in 2014 and the annual fees until FY 2017, see table 1). Under BsUFA I, Company A was able to reduce their application fee by deducting the amount paid in BPD fees from the application fee due when the BLA was submitted on June 2017. This company A paid $1,146,440 at the time of the marketing application submission. ($2,038,100 – $891,660= $1,146,440)

•  The total amount of BsUFA fees paid until after submission of the application: $1,146,440

Please note that company A would have paid an establishment fee of $512,200 and a product fee of $ 97,750 once the submission was approved.

Case Study 2

Our second example is company B wishing to submit their BLA for their Biosimilar Product in December 2018. Company B has been in the program for over four years and has paid $ 1,304,282 in BPD fees ($ 216,910 initial BPD fees in 2014 and the annual fees until FY 2019, see table 1).

Company B, initially thought (when they entered the program) that they would be able to reduce their application fee with the amount paid in BPD fees but under BsUFA II they will have no reduction in their application fee at the time of marketing application submission.

Here is the economic impact on the product development of their biosimilar product:

If company B submits the application in December 2018, it means that company B would have to pay the full application fee (w/clinical data) $ 1,746,745 and would have also paid $ 1,304,282 in BPD fees. Although the company is submitting the application in December 2018, they will still have to pay the BPD fees for FY2019 as these are due on the first business day on or after October 1 of each fiscal year.

•  Total amount of BsUFA fees paid until after submission of the application: $1,304,282+$1,746,745=$ 3,051,027

Please note that company B would have to pay an annual program fee of $304,162 for each biosimilar biological product identified in the application (applicants will not be assessed more than 5 program fees per FY) once the product is approved.

for further information, please see “BsUFA II fees—are you aware of the major changes?” here.

 

Nitisha Pyndiah - Biotech Consulting Services

Nitisha Pyndiah, PhD, is a Consultant where she provides advice for the development of biological, biotechnological, and biosimilar products.

Nitisha provides expertise in the areas of virology, molecular biology, microbiology, immunology, immunogenicity, quality control, GLP and GMP. She prepares and evaluates CMC sections, including FDA meeting documents; and conducts scientific and regulatory gap analyses. She supports technical, strategic, and operational regulatory affairs for recombinant proteins, monoclonal antibodies, and vaccines.

It’s NOT a Snowman, it’s SNOMED!

It’s NOT a Snowman, it’s SNOMED!

By Mary Waters, Senior Consultant, eCTD Publish Services

The FDA updated their Form FDA 1571 and Form FDA 356h in May 2018 to include a few new fields; 6B, 7B, and 15B. This change on the Form FDA 1571 now includes the SNOMED CT Indication Disease Term. SNOMED CT is the acronym for Systematized Nomenclature of Medicine Clinical Terms.

SNOMED International established in 2007 and is responsible for determining the global standard for healthcare terminology. SNOMED CT is considered the most comprehensive and multilingual terminology for clinical healthcare worldwide and is the basis and general core terminology for all electronic health records. There were more than 30 countries involved in contributing, developing, and maintaining SNOMED CT. The FDA has adopted this terminology standard for coding study indications for submissions such as IND, NDA, BLA, and ANDA.

The primary purpose of using SNOMED CT is to encode the meanings in health information, support effective clinical records, provide consistent information in data. Using SNOMED CT allows for a consistent manner to index, store, retrieve and aggregate clinical data across specialties and care sites. These consistent terms are also used in representing the medical conditions in Structured Product Labeling (SPL).

The SNOMED CT nomenclature includes clinical findings, symptoms, diagnoses, procedures, body structure, organisms and other etiologies, substances, pharmaceuticals, specimens, and devices.

To complete the Form FDA 1571, ensuring the completed form passes validation and is not rejected, it’s best to go directly to the SNOMED International website which is found at http://browser.ihtsdotools.org/.

There are currently nine editions to choose from, but for US FDA purposes, please select the United States Edition. Also, please note that the website states that Internet Explorer will not work and to use Google Chrome.

After you have chosen the US Edition, the next page will show you tab choices of Taxonomy, Search, Favorites, and Refset. The next set of tab choices are the Concept Details: Summary, Details, Diagram, Expression, Refset, Members and References.

Using the Search box, if you type in the term “migraine”, the program provides 156 matches for this term, which could be further grouped or filtered. The US National Library of Medicine (NLM) maintains a module of core metadata concepts which is indicated by a US Flag icon.

When completing the Form FDA 1571, the agency is looking for both the Concept Code (e.g. 37796009) and the Disorder (e.g. Migraine). This is the information needed to complete Field 7B.

The other notable change to the Form FDA 1571 is the addition of Field 6B. You now need to indicate if your submission is Commercial or Research. If you select Commercial, you are stating that the product(s) are under investigation that are intended to be commercialized at a later time; and Research is defined as products under investigation that will not or are not intended to be commercialized at a later time. With this change, the FDA is now requiring that commercial INDS will be formatted in eCTD.

The FDA is refining their processes for preparing electronic submissions. These changes should make doing business with them easier, especially for those who are new to this area. If, however you or your firm still need some help after reviewing the instructions, please reach out to us. We can help you not only interpret or choose the appropriate code(s) to use but can also help you properly complete the form. Remember, we are only just a phone call away!

 

 

 

Nitisha Pyndiah - Biotech Consulting Services

Mary is an expert provider of electronic Common Technical Documents (eCTD) publishing services. Since joining HW in 2016, Mary has submitted over 225 electronic submissions through the FDA ESG.