In this blog, I often rail about how unapproved drugs and illegal dietary supplements find their way into the U.S. market through the internet or mail outlets. I’ve wondered why the FDA is not doing more to stop the game of whack-a-mole where, as soon as the FDA makes an enforcement action against one supplier, […]
We posted a blog earlier today (here) regarding the FDA’s announcement that it plans to review a number of drug substances at a two-day meeting, in July, of the Pharmacy Compounding Advisory Committee. Later in the day, the FDA released a document outlining additional plans to reclassify other drug substances, including several peptide drug substances, […]
The FDA has announced a two-day meeting of the Pharmacy Compounding Advisory Committee for the purpose of reviewing certain bulk drug substances nominated for inclusion in the Section 503A bulk drug substances list. The meeting is scheduled for July 23-24, 2026, and it will be held at the FDA’s White Oak Campus. The full notice from the […]
FDA inspectors continue to link equipment maintenance issues to data integrity problems, contamination events, and preventable batch failures. While maintenance activities are often carried out by Engineering, regulators consistently expect the Quality Unit (QU) to exercise meaningful oversight over this action. EU GMPs mirror this expectation, and industry frameworks like ICH Q10, highlight why this oversight […]
In a post on the FDA Law Blog (here), Kurt Karst, Director, Hyman Phelps & McNamara, did a masterful job of outlining some of the FDA budget legislative proposals for 2027. I’ve known Kurt for a very long time, and we usually agree on most topics; however, his take on one of the elements appearing […]
While perusing the current USP <11>, USP Reference Standards, which became effective on December 1, 2025, it was noted that the USP Reference Standard description was amended to state “highly characterized physical materials or digital data demonstrated to have the appropriate qualities to support their intended use as references for comparison in compendial tests.” The General Chapter […]
Two of our Senior Directors, Andy Hopkins and Bob Wittorf, will be speaking at PDA events in Singapore this May 2026, sharing practical regulatory insight on some of today’s most critical pharmaceutical manufacturing and quality topics. These PDA events bring together global regulators, industry leaders, and technical experts to address evolving expectations for manufacturing, contamination […]
A few months before the end of 2025, the FDA requested that Glaxo Smith-Kline (GSK) revise its approved labeling by submitting a supplemental application to its Wellcovorin (leucovorin calcium) to include an indication for cerebral folate deficiency (CFD), a rare disorder. This came after Secretary Kennedy’s thus far unsuccessful hunt for the cause of autism. […]
On Tuesday, April 7th, the FDA announced that the Office of Generic Drugs had approved multiple first generics for Dapagloflozin Tablets. A quick review of the listings for the product in the Orange Book shows that there were a total of fifteen ANDAs approved on Monday, April 6th, which was the first business day that the FDA […]
There’s always a certain energy at PDA Week – the kind that comes from a shared sense that our industry is moving, sometimes faster than we expect. This year in Denver, that energy felt different. More focused. More urgent. And in many ways, more practical. As both an exhibitor and attendee representing Lachman Consultants, I […]
