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.
Here is a list of ten things one must know about Unique Device Identification (UDI).
On Aug. 11, Celltrion announced the completion of their 351(k) filing procedure to FDA on Aug. 8, for its Remicade (infliximab) biosimilar product, Remsima (infliximab).
Avalere will be hosting a conference on the future of market access for diagnostics and personalized medicine.
On July 31, FDA released the details of its draft guidance regulating laboratory developed tests (LDTs).
Avalere impressions on the first FDA biosimilar filing.
As the medical device industry prepares for the next round of user fee negotiations, manufacturer representatives must consider the importance of FDA's approval process transparency, and regular interactive communication.
As the laboratory testing community continues to weather recent policy changes in both regulatory and reimbursement areas - there has been yet another development.
On May 13, FDA released a draft guidance describing the clinical pharmacology data needed to support a demonstration of biosimilarity to a reference product.
On March 26 and 27, FDA's Advisory Panel reviewed two DNA-based colorectal cancer (CRC) screening tests, Epigenomics-Epi proColon® Septin 9 test and Exact Sciences-Cologuard®.
On March 18, FDA released draft guidance containing recommendations for sponsors and new applicants preparing bioavailability (BA) and bioequivalence (BE) data for products in investigational new drug applications (INDs), new drug applications (NDAs) and NDA supplements.
FDA will hold a public hearing on April 1 to receive feedback from key stakeholders on 1) demographic subgroup representation in clinical trials, 2) analysis of demographic subgroup data, and 3) communication of demographic subgroup information to the public.
On Feb. 24, FDA issued draft guidance on exclusivity determinations for certain fixed-combination drug products (FCDs).
FDA has now confirmed that the first widespread generic-drug equivalency testing program was initiated last September (without public notice).
On Feb. 18, FDA released guidance outlining how an applicant can obtain FDA feedback on a potential or planned medical device submission reviewed by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), including the Pre-Submission (formerly pre-Investigational Device Exemption (pre-IDE)) program.
On Feb. 10, the Government Accountability Office (GAO) released a report discussing the results of its drug shortages analysis, and reported that although the total number of ongoing drug shortages continues to increase, new drug shortages decreased in 2012.
On Jan. 14, FDA issued draft guidance for industry called "Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics."
On Jan. 6, FDA released final guidance outlining the qualification process for drug development tools (DDTs).
Join Avalere's Brenda Huneycutt, FDA Policy & Regulatory Strategy Practice, who will be moderating a panel with Avalere's Jenny Gaffney and other leading experts at the Biotech Showcase in San Francisco on Tuesday, January 14th at 8am, titled "FDA: where it's going and how it affects biotech."
On Nov. 27, FDA released three draft guidances on the regulation of compounding pharmacies following the enactment of the Drug Quality and Security Act (DQSA).
On Nov. 22, FDA issued a warning letter to 23andMe, Inc., asking them to immediately discontinue the marketing of their saliva collection kit and Personal Genome Service (PGS) Kit.