Since July 9, 2012, the day that the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public 19 Law 112-144) was signed into law, drug products are deemed “adulterated for which a manufacturer processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or […]
The FDA has revised the guidance, originally issued in July 2022, titled Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe (here) to include additional information as required relative to the performance goals outlined in the commitment letter for GDUFA III. While there aren’t many changes in the revision, it is certainly […]
Twice a year, the FDA publishes an update of the List of Off‑Patent, Off‑Exclusivity Drugs without an Approved Generic (see here). This list is designed to generate interest from the industry in increasing competition among such products. It is made up of two parts. Part I is for drugs for which the path to approval is […]
I usually don’t blog about Federal Register (FR) notices on collections of information as they are usually not that exciting and typically just announce the Agency’s collection of certain information as is an OMB requirement under the Paperwork Reductions Act of 1995 (as an aside, there sure does seem to be a lot of paperwork […]
Well, here we are at the conclusion of the second month of FY 2023 and we can still only report unofficial approval numbers. At least we know the reason why (see previous post here), but it’s very important to continue to track these metrics as approvals are the lifeblood of the generic pharmaceutical industry. We […]
The FDA is usually pretty consistent with the timing of their publication of official OGD metrics, especially when it comes to the publication of the Generic Drugs Program Activities Report – Monthly Performance. The first month of official stats has not yet been available and it is almost December. I was curious about the delay, […]
It is always interesting to see how the Agency works when one action could trigger another action. In the Federal Register pre-publication page (here) this morning, the “Food and Drug Administration (FDA) [announced that it] is withdrawing approval of new drug application (NDA) 019832 for SULFAMYLON® (Mafenide Acetate, USP) Powder for 5% Topical Solution, held […]
The November 23, 2022 issue of the Federal Register (here) contained a Proposal To Withdraw Approval of a New Drug Application for Bufferin (Aspirin) Tablets (NDA 006499) originally approved June 30, 1948 thought to still be held by Bristol Myers. The Agency proposed to withdrawal this NDA for failure to submit required annual reports. It […]
Outsourcing compounding facilities are those that register with the FDA as such under section 503B of the Federal Food Drug and Cosmetic Act. According to the FDA, “[O]ne of the conditions that must be met for a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the FD&C Act is […]
There has been turmoil in the world; everything seems to have gone crazy. It’s hard to find faith or even truth in our politicians. Laws have been broken and our democracy was almost broken. But, with the 2022 mid‑year election, we seem to have taken a step back from the precipice. In thinking about our […]
