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Category Archives: Regulatory Affairs

RAPS Regulatory Convergence 2017: A Recap

October 11, 2017 | Mark A. Cierpial, PhD, RAC; Principal Regulatory Consultant | Regulatory Affairs

The Regulatory Affairs Professionals Society (RAPS) held another successful annual meeting (or “Regulatory Convergence” as it’s called) last month. This year’s Convergence was held at the Gaylord Resort at National Harbor on the DC Waterfront and offered more than 70 educational sessions presented by over 200 expert speakers from around the world. In addition, 135 companies, offering a wide range of regulatory services and solutions, were in attendance in the exhibit hall.

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Will the FDA Change the Way it Regulates Off-Label Promotion? One Court Case that May Have Helped Pave the Way

April 13, 2017 | Ashley Godfrey, PhD, RAC, Clinical Research Scientist II | Regulatory Affairs

When it comes to off‑label promotion – promoting a prescription drug for a use that is not included in its approved labeling – the FDA has historically taken the position that doing so risks criminal misbranding of the product under the Food, Drug and Cosmetic Act (FD&CA). However, a number of recent court cases challenging this position on the basis that it violates the First Amendment rights of drug companies have paved the way for a potential change in the way FDA will be regulating off-label promotion. We are eagerly awaiting the release of a new FDA guidance on off-label communication. This guidance will be the subject of another blog post when it becomes available. But in the meantime, I thought I would briefly discuss the relevant history of one of the court cases, Amarin Pharmaceuticals, Inc. (Amarin) versus FDA, that helped put the potential policy changes in motion.

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Emerging Key Concepts in Biosimilar Development

March 8, 2017 | Kathryn Tworkoski, PhD, Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting

Biosimilars are a relatively new class of therapeutics. To date, only 4 biosimilars have been approved by the FDA (ZARXIO™, INFLECTRA®, ERELZI™, and AMJEVITA®); 3 of those 4 approvals occurred within the past year, and all 4 approvals occurred within the past 2 years! In this post, we’re going to take a quick look at the FDA’s current thoughts on biosimilar development, as well as a few key concepts in the field.

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IRB Meetings — Beyond The Regulations

December 15, 2016 | Ashley Godfrey, PhD, RAC, Clinical Research Scientist II | Regulatory Affairs

Have you ever wanted to know what goes on at a convened Institutional Review Board (IRB) meeting? What does the board talk about, how is each clinical research study evaluated, and what kinds of questions will the board raise before approving a study?

These were all questions I had when I joined a local IRB at a large institution.

The experience I had serving as a voting board member and discussing clinical research on the other side of the process has provided me with a valuable perspective.

I hope that sharing some of the things I have learned along with providing some general information about IRB regulations will shed some light on the IRB’s process of review.

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Final Rule Confirms, Posting of Study Results on ClinicalTrials.gov Will be Required for Unapproved Products

November 29, 2016 | Hazar Awad Granko, RPh, PhD, Senior Director, Regulatory Affairs | Regulatory Affairs

In a previous post, we told you about the National Institutes of Health’s (NIH) Notice of Proposed Rulemaking (NPRM) on expanded clinical trial registration and results submission on ClinicalTrials.gov. The Final Rule has now been issued and significantly expands the registration and results reporting requirements for clinical trials.

Background
The Food and Drug Administration Amendments Act of 2007 (FDAAA) required Sponsors of certain clinical trials to register on ClinicalTrials.gov, but only required results reporting for trials of drugs, biologics, or devices that were approved, licensed, or cleared by the FDA.

In a push for expanding transparency and advancement of public health, the NIH issued an NPRM in November 2014 proposing to expand these requirements. After receiving over 900 comments from various companies, organizations, and individuals, and nearly 2 years later, the NIH has now issued a Final Rule on clinical trials registration and results reporting.

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