Taking a look at the unofficial approval information on the FDA website through December 16th, we found only twenty‑five ANDAs receiving full‑approval actions and six receiving tentative‑approval actions. That is a total of (obviously) thirty‑one approval actions. Given that number, if the OGD could double its approval output by the end of the month, that would […]
Well, the new statistics started rolling off the assembly line last night and appear in a new report that combines the generics monthly statistical report and the Quarterly Report. The new name of the report, which we discussed in a blog post (here), is the Generic Drugs Program Monthly and Quarterly Activities Report. We will […]
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 […]
The 2022 ISPE Pharma 4.0 and Annex 1 Conference, which just concluded in Vienna, Austria, highlighted the exploding value of digitization in pharmaceutical aseptic manufacturing and quality, and how digitization will play a key role in the attainment of sustainable and robust compliance for the new revision of EU GMP Annex 1 for manufacture of […]
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 […]
Processing of the laboratory instrumentation output such as the processing of chromatographic raw data continues to be a focus of global health agency investigators. This is not surprising, as the investigator will be aware of the Data Integrity (DI) risks with such a manual operation, where there is the potential of selectively adjusting integration settings […]
On Tuesday December 13, Lachman President and CEO, Fran Zipp will be participating on a panel in a live webinar on “Excelling in a Multigenerational Workplace” as part of the DCAT Alliance for Industry Women Committee. This issue is one that transcends the pharmaceutical industry and is certainly not experienced exclusively by females. The varying […]
Today’s pre-publication of the Federal Register contains a proposed rule (here) that will require the expansion of the current IND annual report. “Current § 312.33 requires sponsors that have an IND in effect to submit an annual report that must contain individual study information, which generally includes brief summaries of the status of each ongoing […]
