Regulatory Strategy and FDA Policy

The development of drugs, biologics, and medical devices follows rigorous paths to ensure safe and effective medicines. We create FDA regulatory engagement strategies and help clients interpret FDA regulations, guidance, and the likely impact of legislation. Interpreting FDA priorities, resources, User Fee Acts, and label and promotion requirements, our experts can help you manage your pipeline.

Industry Funding Spurs FDA’s Review Activities for Prescription and Generic Drugs

User fees are increasingly central to the funding of the drug and device review programs, and in some cases these fees account for a larger proportion of the Food and Drug Administration's (FDA) budget than congressionally-appropriated monies. For example, user fees account for 68 percent of the FDA's review budget for prescription drugs, while 58 percent of the review budget for generic drugs comes from user fees.

Spotlight On: Clinical Trials in the Development of Biosimilars

In Biosimilars, Avalere's Gillian Woollett shares commentary on future considerations for the role of clinical trials in the development of biosimilars.

New Study Analyzes FDA Advisory Committees’ Trends in First Three Years of Current User Fee Era

The US Food and Drug Administration's (FDA) Advisory Committee (AdComm) process remains a source of significant uncertainty for medical product manufacturers, despite FDA's guidelines in the Code of Federal Regulations (CFR)1 and in guidance.2 While the AdComm process is generally the same across Centers,3 each AdComm is unique and subject to the expertise and opinions of individual panel members, opinions voiced during the public comment period, and challenges exclusive to each new product or indication.

Interview: Compassionate Use

When life sciences companies consider whether to allow compassionate use—access to unapproved investigational treatments outside of clinical trials—there are no easy answers. Brenda Huneycutt gleans insight from Arthur Caplan, PhD, and Alison Bateman-House, PhD, from the New York University Langone Medical Center Division of Medical Ethics on some of the many questions that life sciences companies should ask themselves before implementing a compassionate use policy.

Focus on Innovation: FDA’s Rare Pediatric Disease Priority Review Voucher Program

On June 30, 2015, Gayatri R. Rao, MD, JD, of the FDA's Office of Orphan Products Development (OOPD) presented an overview on the Rare Pediatric Disease Priority Review Voucher Program. Dr. Rao discussed the background and purpose of the program, application and review process, sunset provision, and what's next for the program followed by a short question and answer session.

FDA and Sponsors Discuss Quality Challenges in the Breakthrough Therapy Pathway

Need to Know: On June 10, Friends of Cancer Research held a public meeting to discuss how sponsors and FDA may be able to expedite rate-limiting steps in Chemistry, Manufacturing, and Controls (CMC) and current Good Manufacturing Practices (cGMPs) for breakthrough therapy designated products, while ensuring an adequate supply of safe and efficacious product at the time of approval.

FDA Receives First Biosimilar Application for a Monoclonal Antibody

On August 11, Celltrion announced the completion of their 351(k) filing procedure to FDA on Aug. 8, for its Remicade (infliximab) biosimilar product, Remsima (infliximab).

Analysis: First FDA Biosimilar Filing

Avalere impressions on the first FDA biosimilar filing.

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