Manufacturing Consideration for Cellular and Gene Therapy Products During COVID-19 Public Health Emergency
By Rose Pagano and Suzanne M. Sensabaugh, MS, MBA Recently, the FDA released the guidance “Manufacturing Consideration for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency.” This guidance is meant to supplement...
read moreFDA Reissues EUA Guidance for use of COVID-19 Convalescent Plasma
By Rose Pagano and Suzanne M. Sensabaugh, MS, MBA In August, the FDA issued an Emergency Use Authorization (EUA) for COVID-19 convalescent plasma for the treatment of hospitalized COVID-19 patients. Since then, the FDA has released a revised EUA. The COVID-19...
read moreIdentification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers
By Rose Pagano and Suzanne M. Sensabaugh, MS, MBA The intention of this guidance is to clarify FDA expectations related to facility information that must be included in original new drug applications (NDA), abbreviated new drug applications (ANDA), original biologics...
read morePostmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act
By Rose Pagano and Suzanne M. Sensabaugh, MS, MBA This guidance was recently released and serves to distribute information concerning the enactment of section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This section of the law allows FDA...
read moreSubmitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics
By: Rose Pagano and Suzanne M. Sensabaugh, MS, MBAThe FDA released this guidance to help sponsors and applicants using real-world data (RWD) to produce real-world evidence (RWE) for a regulatory submission. This encompasses submissions for investigational...
read morePostmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff
By Rose Pagano and Suzanne M. Sensabaugh, MS, MBA The FDA recently released a final guidance concerning postmarketing safety reporting for combination products. This is relevant for combination product applicants, whose products are made of two or more...
read moreOncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations Guidance for Industry
By Rose Pagano and Suzanne M. Sensabaugh, MS, MBAThe intention of this guidance was to help sponsors in assessing reproductive toxicity (mostly for the effects on embryo-fetal development (EFD)) for oncology pharmaceuticals and outline recommendations for...
read moreDevelopment of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations
By Rose Pagano and Suzanne M. Sensabaugh, MS, MBA The FDA recently released this guidance to detail the agency’s recommendations for the design and evaluation of comparative analytical studies to demonstrate that a proposed therapeutic protein product is...
read moreConsiderations in Demonstrating Interchangeability With a Reference Product Guidance for Industry
Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry:By Rose Pagano and Suzanne M. Sensabaugh, MS, MBA The purpose of this guidance is to aid sponsors by showcasing that a proposed therapeutic protein product...
read moreThe FDA “Deemed to be a License” Provision of the BPCI Act changes “approved” biologics to “licensed” biologics
By Rose Pagano and Suzanne M. Sensabaugh, MS, MBA Biological products have historically been approved under two laws: The Public Health Service Act (PHS Act) through a Biologics License Application (BLA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act)...
read moreSmallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention Guidance for Industry
By Rose Pagano and Suzanne M. Sensabaugh, MS, MBA The purpose of the guidance: Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention is to help sponsors involved in the clinical development of drugs for the treatment or...
read moreWhat’s It All About?—KASA
What’s it all about, KASA?By Mary Waters There’s been some buzzing about the FDA instituting a new review system called Knowledge-aided Assessment and Structured Application (KASA). In September 2018, the FDA met with the Pharmaceutical Science and...
read moreStandards development and the use of standards in regulatory submissions reviewed in CBER
By Nitisha Pyndiah, PhDIn a draft guidance document released on December 2017, FDA described CBER’s recommendations on the use of standards in product development and the use of such standards in CBER’s managed review process. Mainly, FDA promotes...
read moreCommunication between Sponsor and FDA – Best Practices
By Mary WatersAnyone 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...
read moreHW was at FDA for the Part 15 public hearing
By Nitisha Pyndiah, PhDHW reportsHW 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...
read moreHyperlinks
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...
read moreBiosimilar 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...
read moreBiosimilar 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...
read moreIt’s NOT a Snowman, it’s SNOMED!
By Mary WatersThe 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...
read moreFDA’s Thoughts on Adolescents in Adult Clinical Oncology Trials
By Rose Pagano and Suzanne M. Sensabaugh, MS, MBA Pediatric cancer is frequently different than cancer found in adults and requires unique treatments. Conversely, certain cancers (soft tissue and bone sarcomas, central nervous system tumors, leukemias and lymphomas,...
read moreFDA releases Q&A Guidance After Confusion Surrounding S9A Nonclinical Evaluation for Anticancer Pharmaceuticals Guidance
By Rose Pagano and Suzanne M. Sensabaugh, MS, MBA The S9 Nonclinical Evaluation for Anticancer Pharmaceuticals Guidance (ICH S9) has resulted in confusion and challenges amongst its users. S9 Nonclinical Evaluation for Anticancer Pharmaceuticals Questions and...
read moreBsUFA II fees—are you aware of the major changes?
By Nitisha Pyndiah, PhD The FDA guidance document Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 explains the changes, but let’s review the most important items. Quick introduction The Biosimilar User Fee Act of 2012 (BsUFA I) added sections to...
read moreFDA Public Docket for Technical Specifications
By Mary Waters Here’s Your Opportunity to be Heard The Food and Drug Administration (FDA) has established a public docket so that anyone can share information, comments, and ideas on any matters related to the use of their technical specifications or technical...
read moreUpdate to the eCTD “Mandate”
By Mary WatersThe FDA had a mandate for submitting in eCTD format Drug Master Files (DMFs) (other than Type III – packaging material). Luckily for some, there was a reprieve as the FDA extended that date another year until 05 May 2019. That said, there are still other...
read moreHow to Survive and Thrive in FDA Meetings on BsUFA Products: Key Differences Between the Original and Revised Guideline
By Rose Pagano and Suzanne M. Sensabaugh, MS, MBA Time is money, and to help you save both time and money the FDA recently released a revised version of their Guidance for Industry on Formal Meetings between the FDA and Biosimilar Biological Product Sponsors or...
read moreFDA Revisions on Formal Meetings between FDA and Sponsors of PDUFA Products
By Benjamin Policicchio, PhD and Suzanne M. Sensabaugh, MS, MBA In December 2017, the FDA published an update to the 2009 “Formal Meetings Between the FDA and Sponsors of Applicants” to detail new information for sponsors of Prescription Drug User Fee Act (PDUFA)...
read moreClarification of Roles and Responsibilities and Proposed Future Reviews of and Updates to the Coordinated Framework-Part 4
By Benjamin Policicchio, PhD and Suzanne M. Sensabaugh, MS, MBA Welcome to the fourth and final blog post in our mini-series focused on the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. In the three previous posts, we provided...
read moreFDA Updated their Guidance Document about “Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues and Cellular and Tissue-Based Product”.
By Nitisha Pyndiah, PhD Source: CDC/ Cynthia Goldsmith (2016). This is a transmission electron microscopic (TEM) image of the Zika virus, which is a member of the family, Flaviviridae. Virus particles are 40nm in diameter, with an outer envelope, and an inner dense...
read moreInteragency Communication and Coordination Between FDA, EPA, and USDA – Part 3
By Benjamin Policicchio, PhD and Suzanne M. Sensabaugh, MS, MBA Part 3 - Interagency Communication and Coordination Between FDA, EPA, and USDA Welcome to part three of this mini-series revolving around the recently-released 2017 Update to the Coordinated Framework for...
read moreWhat Do You Need to Know About Immunogenicity?
By Nitisha Pyndiah, PhD One of the most challenging parts of your drug development is making sure that your drug does not elicit a detrimental immune response in the patient also known as immunogenicity. This immunogenic response can impact the efficacy and safety of...
read moreFDA Interchangeability Guidance Part 2
By Nitisha Pyndiah, PhD To follow up our previous part 1 about the analytical data required to demonstrate interchangeability, let’s look into the clinical studies required. What clinical studies are required to demonstrate interchangeability? To demonstrate...
read moreMay 5th Marks the Deadline for INDs and DMFs
By Mary Waters Cinco de Mayo is widely interpreted as a celebration of Mexican culture and heritage. Today, celebrators mark the occasion with parades, parties, mariachi music, Mexican folk dancing and traditional foods such as tacos and mole poblano and consuming...
read moreRegenerative Medicine Advanced Therapy Designation: Regulatory Shortcuts for Market Approval
By Roushan Afroze and Suzanne M. Sensabaugh, MS, MBA Near the end of 2016, the United States Congress enacted the 21st Century Cures Act to expedite the development and review of biologics that address unmet medical needs. This is to be accomplished by introducing a...
read moreFDA Will Not Delay the Implementation of the eCTD DMF Mandate Again
Mary WatersAt the DIA Regulatory, Submission and Information Management (RSIDM) conference held in Bethesda, MD, February 2018, the FDA directly stated that they would not delay the implementation of the eCTD DMF mandate again.If your company/organization has taken a...
read morePart 2: Roles and responsibilities of the primary agencies that regulate the products of biotechnology
By Benjamin Policicchio, PhD and Suzanne M. Sensabaugh, MS, MBA In part 1 of this mini-series discussing the newly-released 2017 Update to the Coordinate Framework for the Regulation of Biotechnology, we discussed some of the background relevant to understanding...
read morePart 1: 2017 Update to the coordinated framework for the regulation of biotechnology
By Benjamin Policicchio, PhD and Suzanne M. Sensabaugh, MS, MBA In 2017, a joint effort between the U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA) produced the “2017 Update to the...
read moreFDA Releases draft guidance on statistical approaches to evaluate analytical similarity between biosimilars
The US Food and Drug Administration (FDA) recently released the final version of the guidance document about nonproprietary naming of biological products. This long awaited document applies to originator biological products, related biological products and biosimilars...
read moreHW reports advice from FDA, CDER reviewers
What are the benefit-risk considerations during the development of your drug and how to avoid clinical hold? On September 27-28, the FDA SBIA REdI Fall Conference took place in Rockville, MD. HW was there and reports highlights of the drug track of the meeting. FDA...
read moreFDA interchangeability guidance released: Is your company ready?
By Nitisha Pyndiah, PhD Part 1: Introduction to interchangeable products and the analytical data required Introduction In the last decade, there has been an emergence of cutting-edge technologies used to discover or create promising biological products. This...
read moreThe FDA and Scientific Experts Discuss Infectious Disease Risk
By Nitisha Pyndiah, PhD On February 8-9, 2017 the Food and Drug Administration (FDA) organized a public workshop entitled ‘Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-based Products’. The purpose...
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