In an unusual move, the FDA posted a guidance document on its webpage describing how to handle tentative approvals titled “ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs” (here) prior to its announcement in the Federal Register with this accompanying note: “We are posting this document on the FDA website […]
The Office of Generic Drugs (OGD) has taken great pride in meeting all of its GDUFA goals (including most, if not all, ANDA review goal dates). But, Houston, we may have a problem! Here are some facts that may have the OGD worrying into the future: December is typically one of the largest months for […]
In 2018, the FDA says it approved fifty-nine new molecular entities, which included a whopping thirteen biosimilar products. All of the NME product approvals can be found here. It is important for you the read the FDA explanation of how the Agency is defining NMEs for the purposes of this report and stay focused on […]
I read four articles this morning that blamed high generic and brand name prices on everything from the confusion between list price and transactional pricing (here), to too much drug regulation (here), to PBMs and to the lack of negotiations between Medicaid and drug companies (here and here). I am sure that there are many […]
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 […]
Many thanks to the FDA for publishing several important new and revised guidances and a proposed rule related to the Biopharmaceutical industry this week. These include a finalized version of the “Deemed to be a License” Guidance for industry (here) with several important revisions and additions relative to the previously published draft, a Q&A Guidance […]
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Today, the FDA made final and released a revision to a 2016 draft guidance titled Data Integrity and Compliance With Drug CGMP Questions and Answers (here).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 […]
Congress has long been concerned that firms were not meeting their requirements for timely completion of postmarketing requirements and commitments (PMRS/PMCs) made at time of approval or post-approval in supplemental applications. In 2007, Congress passed the Food and Drug Administration Amendments Act (FDAAA) and, on September 27, 2007, the President signed the legislation into law. […]
