FDA Regulatory Pathways
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.
Tom Kraus, who most recently served as the chief of staff at the FDA, will be joining Avalere as senior vice president.
Biosimilars have the opportunity to foster competition, but policy and market barriers limit the growth of a functioning market.
The 21st Century Cures Act requirement to post compassionate use policies may explain increase.
Extension of the Sunset Clause provides additional opportunity for the FDA to award vouchers and for transference of vouchers from recipients to other sponsors.
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.
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.
The US Food and Drug Administration (FDA) makes its medical product marketing approval decisions based on a risk–benefit determination of safety and effectiveness.
Listen as our expert, Jay Jackson, discusses recent final guidance issued by the FDA on compassionate use.
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.
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.
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.
In Biosimilars, Avalere's Gillian Woollett shares commentary on future considerations for the role of clinical trials in the development of biosimilars.
The U.S. 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 (C.F.R.)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.
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.
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.
On June 30, 2015, Gayatri R. Rao, M.D., J.D., 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.
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.
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."
FDA passed the Final Rule for Unique Device Identification (UDI) on September 24, 2013 with the rollout of Class III devices one year later.
On October 13, JAMA Internal Medicine published a study on the available clinical validity and clinical utility of pharmacogenomic information included in drug labels.