The FDA released a summary table from a study report that was designed to help applicants for extended-release (ER) and delayed-release (DR) products; the FDA is aware of the types of deficiencies that are being seen and is making an effort increase the first-cycle approval rate for these products. The report summary (here) covers 186 […]
In the prepublication of the Federal Register today, the FDA asked for comments on issues related to trying to reduce the confusion on maximum daily intake (MDI) and maximum daily exposure (MDE) limits in its Inactive Ingredient Database (IID). The industry uses the IID to identify the level of inactive ingredients that may be safely […]
First of all, Happy St. Patrick’s Day! The luck of the Irish prevailed last night as, one minute after midnight on March 17th, the Notre Dame Fighting Irish basketball team won its NCAA play-in game in double overtime for a chance to play #6 seed Alabama on Friday. I guess I have some luck too […]
The FDA published the OTC User Fee rates for FY 2022 today These rates were announced this morning in a Federal Register notice (here) and cover fees for OTC manufacturing facilities, contract manufacturing organizations (CMO), and OTC monograph order requests (OMOR) for which there are tier 1 and tier 2 requests. A comparison of the FY […]
For many drug products, determining the qualitative (Q1) and quantitative (Q2) formulation for purposes of establishing sameness of formulation to that of the innovator or reference-listed drug (RLD) product can be quite a chore. If you can get it right, then it may be possible to obtain a waiver of in vivo bioequivalence requirements for […]
The MHRA Good Clinical Practice Symposium was a virtual event this year due to COVID‑19. More than 800 individuals from over forty countries across the globe attended. Throughout the three‑day event, speakers provided their perspectives on clinical trials from their roles as inspectors, assessors, and reviewers representing the MHRA, FDA, and Health Canada. The agenda provided […]
On February 24, 2022, the Small Business and Industry Assistance (SBIA) group at the FDA hosted a webinar titled Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA (you can view the recording here). The goal was to describe the eight major changes to the August 2021 revision to the guidance Bioequivalence Studies […]
I believe everyone likes seeing the progress of ANDA approval actions, and hold that as the primary measure of success of OGD. I know that has been the case ever since Hatch-Waxman was implemented in November of 1984. So I continue to track this metric very closely and at least through the morning of March […]
The FDA has published its guidance on Voluntary Recalls (here), revising the initial draft guidance issued April 24, 2019. The Agency notes that “[I]n addition to editorial changes made to improve clarity, changes from the draft to the final guidance include the addition of the terms correction and market withdrawal to the terminology section, the […]
Yesterday, the FDA issued its final guidance on the Pre-Launch Activities Importation Requests (PLAIR), a process that permits importation of unapproved NDA, ANDA and CDER-regulated BLA products into the United States in anticipation of imminent approval. The original draft guidance was issued on July 24, 2013. The FDA says that it considered comments received on […]
