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...

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...

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...

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...

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...

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...

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...

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...

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...

 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)...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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,...

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...

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...

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...

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...

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...

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)...

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...

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...

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...

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...

  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...

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...

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...

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...

  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...

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...

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...

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...

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...

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...