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 […]
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 […]
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 […]
In an FDA announcement today titled Approved First Generic for Apokyn Injection Cartridges Requires Separately Packaged Pen (here), the Agency noted that this is the first generic approved without a delivery device. While I am aware of other FDA approvals where an off-the-shelf autoinjector was available to inject a prefilled syringe (that can be procured […]
In the prepublication edition of the Federal Register, the proposed rule on revisions to the Quality System Regulation was published today and may be found here. According to the notice, the Agency “is proposing to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with […]
The most popular program of each year’s AAM Annual Meeting is always the CEO unplugged session. Oftentimes there are significant disagreements between the different CEOs regarding strategy, but this year there was almost complete agreement on strategic issues, policy, the marketplace, and regulatory issues. The four panelists were Sven Dethlefs, Ph.D, Executive Vice President, North […]
(Not that we had anything to do with Califf’s confirmation but we are all glad that this is in the Agency’s rearview mirror and it now has a permanent rudder for the foreseeable future.) Anyway, the AAM annual meeting is in full swing and I thought that I would give a few bullet points of […]
On February 2, 2022, I posted a blog on the Agency’s Guidance Agenda for 2022 (here) and chose seventeen of the ninety‑eight guidances listed that were my favorites for a number of reasons, but most of all due to what I felt was their significance. And, today, one of the guidances I had selected was […]
January 2022 was a much better month than the previous, thanks to (what looked like) an end‑of‑the‑month approval flurry as twenty‑seven ANDAs received full‑approval actions in the last five business days. Remember that these are unofficial totals gathered from the FDA’s Recent New and Generic Drug Approvals list (here) and the Agency’s All Approvals List […]
