After just over five years, the FDA is officially withdrawing its controversial proposed labeling rule for generic drugs. The advance publication notice in the Federal Register can be found (here). The proposed rule would have permitted ANDA holders to unilaterally revise its labeling via a CBE-0 supplement to include new or different safety information or […]
Today, the FDA made final and released a revision to a 2016 draft guidance titled Data Integrity and Compliance With Drug CGMP Questions and Answers (here). The document was revised “based on comments made to the draft as well as requests for FDA thinking on current best practices and additional examples.” The guidance does have […]
Well, since the first draft guidance on the “deemed approved” transition provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), we have been waiting to learn more about the specific process and for answers to a number of questions. FDA just issued a second revision of the question and answers document […]
On Monday, the FDA revised the “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance” (here). The initial draft guidance issued in 2014. According to the Federal Register Notice that announced the guidance revision (here), the FDA notes that “[t]his revised draft guidance reflects the FDA’s […]
In a prepublication Notice from the Federal Register (here), the field of products permitted for compounding by 503A and 503B compounders decreased by two. The Agency will publish a final rule on Tuesday titled List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness. The Agency […]
Dr. Kathleen (Cook) Uhl said there would be good months and not-so-good months. Well, although the official numbers for November are not yet posted, it looks like OGD will have another good month. Not a record breaker, but close, unless there are at least 4 more not yet reported approval actions lurking somewhere in the […]
The Office of Generic Drugs has issued a guidance titled “Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA” (here) that addresses OGD expectations, procedures for obtaining such meetings, and timeline for scheduling and having the meetings. As the FDA notes in the guidance: “FDA will only grant post-CRL meeting requests that pose […]
While we are thankful for the FDA’s work on issuing bioequivalence guidance documents, we worry about the impact of the constant and sometimes significant revisions to previously issued draft or final bioequivalence guidance recommendations on the review and approval process. It seems that we are not alone! In remarks made at the November 27th FDA […]
Join former FDA Investigations Branch Director Ricki Chase –now with Lachman Consultants – as she draws on her 16 years of agency experience to bring you the latest insights into FDA inspections, interactions and expectations. Compliance 360° is hosted by Medtech Insight PODCAST LINEUP November 28, 2018 Compliance 360° Part 14: Leverage FDA Data To […]
I just read the Association for Accessible Medicines’ (AAM) White Paper entitled “Ensuring the Future of Accessible Medicines in the U.S., Avoiding Shortages & Ensuring Competition for America’s Patients” (here) that is being entered into the record at the FDA-sponsored meeting Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions held on November […]
