In my own humble opinion, Scott Gottlieb’s resignation will come as a blow to both the industry and the public health of our nation. Dr. Gottlieb will stay in his position for about a month. There is no speculation as to whom his replacement will be, and, while some of the news outlets cite his […]
The FDA has revised and finalized a guidance document, originally issued in draft on March 26, 2018, entitled Evaluation of Bulk Drug Substances Nominated for Use in Compounding under Section 503B of the Federal Food, Drug, and Cosmetic Act (here). After the posting of the draft guidance, the FDA says that it received approximately sixty […]
Today, the FDA issued a guidance titled Quality Considerations for Continuous Manufacturing (here). Talk about a controversial proposition! The generic industry has long held that implementation of continuous manufacturing might not be appropriate for their business. Why? I am not always clear on the answer to that question, but change is always difficult, especially when […]
To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year. The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as […]
Ricki Chase, Director, Compliance Practice, authored an article published in Medtech Insight, “How Device Makers Can Leverage FDA Data to Uncover The Agency’s Current Thinking on Compliance”. In this article, she discusses how manufacturers can use information available online from inspectional observations, warning letters, and product recalls to ascertain FDA’s priorities with regards to compliance […]
Today, the FDA made final and released a revision to a 2016 draft guidance titled Data Integrity and Compliance With Drug CGMP Questions and Answers (here).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Well, since the first draft guidance on the “deemed approved” transition provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), we have been waiting to learn more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 […]
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 […]
