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.
Five Obstacles to Competition in the United States Biologics Market
Biosimilars have the opportunity to foster competition, but policy and market barriers limit the growth of a functioning market.
Manufacturer’s Compassionate Use Policies: Companies with Posted Policies More Than Doubled Since September 2016
The 21st Century Cures Act requirement to post compassionate use policies may explain increase.
FDA Priority Review Voucher Programs: Incentive for Industry to Develop Novel Treatments
Extension of the Sunset Clause provides additional opportunity for the FDA to award vouchers and for transference of vouchers from recipients to other sponsors.
Podcast: E2 – Highlights of FDA and NIH in 21st Century Cures
The final signing of the 21st Century Cures Act is the culmination of 3 years of efforts by lawmakers in the House and Senate to expedite developing and making available new treatment options. In the final episode in our series, Jay Jackson discusses what changes are on the horizon for products under The Cures Act.
FDA Has Received $7.67 Billion from Manufactures to Fund Drug Review
Since 1992, the Food and Drug Administration (FDA) has collected $7.67 billion in user fees from pharmaceutical manufacturers to fund drug reviews based on an Avalere analysis of FDA data.
Podcast: An Overview of FDA’s Expanded Access Guidances
Listen as our expert, Jay Jackson, discusses recent final guidance issued by the FDA on compassionate use.
Commercial Uncertainty Remains as US Biosimilar Pipeline Matures
With the recent announcement of the U.S. Food and Drug Administration's (FDA) acceptance of a submission for approval of a second biosimilar to Remicade (infliximab), questions remain for biologics manufacturers, payers, prescribers, and others as to how a mature biosimilars pipeline will begin to evolve in the United States and whether a sustainable competitive specialty market will develop.
Podcast: FDA Efforts in Patient Engagement
In recent years, stakeholders have increasingly become aware of the potential opportunities surrounding incorporation of the patient perspective into early stages of drug development. Listen to Debleena Sengupta discuss how patient input is evaluated and incorporated into the FDA's decision-making process.
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.
Industry Awaits FDA’s Final Guidance Regulating Laboratory Developed Tests – What Does it Mean and Where Do We Go Next?
As the FDA and the clinical laboratory industry continue to battle over the agency's draft guidance regulating laboratory developed tests (LDTs), and as election year looms, the FDA may advance its issuance of a final guidance.
Podcast: 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.
Stakeholder Input in the Harmonization of U.S. and Canadian Drug Development Regulations
On April 13, the Federal Register announced a public meeting entitled "Preparations for International Conference on Harmonization Steering Committee and Expert Working Group Meetings in Fukuoka, Japan."
UDI Lineage – UDIs Not Linked When a Device Changes Ownership, Potentially Causing Patient Harm and Provider Confusion
FDA passed the Final Rule for Unique Device Identification (UDI) on September 24, 2013 with the rollout of Class III devices one year later.
JAMA Study Shows Drug Labels Rarely Demonstrate Clinical Utility
On October 13, JAMA Internal Medicine published a study on the available clinical validity and clinical utility of pharmacogenomic information included in drug labels.
Unique Device Identification (UDI) – 10 Things You Need to Know
Here is a list of ten things one must know about Unique Device Identification (UDI).
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).