With four and a half months remaining in fiscal year 2026, the Center for Drug Evaluation and Research (CDER) has published the list of 85 new or revised guidance documents that it plans to release this year! The document (here) categories along with the number of anticipated guidances are as follows: Administrative/Procedural – 8 Artificial […]
The list is long (here) and there are some interesting regulatory items found in the agenda for FDA. Take some time and peruse them all as I will just highlight a few items of interest in this post. Here are some of the proposed rules that caught my attention: Current Good Manufacturing Practice for Outsourcing […]
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 March 20, 2026, the FDA issued a Warning (here) notifying healthcare providers and patients that Carbidopa/Levodopa drug products can cause vitamin B6 deficiency and vitamin B6 deficiency-associated seizures. The warning instructs healthcare providers to monitor B6 levels in their patients taking the combination therapy, and recommends taking a baseline B6 level at the beginning of treatment. B6 […]
The FDA announced (here) that it has approved leucovorin calcium for “cerebral folate deficiency (CFD), a neurological condition that affects folate (a vitamin essential for brain health) transport into the brain. Individuals with cerebral folate deficiency have been observed to have developmental delays with autistic features (e.g., challenges with social communication, sensory processing, and repetitive […]
Dr. Makary has indicated that the FDA will take an aggressive enforcement stance on GLP-1 compounded products as well as action on misleading advertising for such products. He has also indicated that the FDA will take decisive action against compounders that produce copies of approved drug products that do not have a required clinical difference. […]
Senator Rick Scott of Florida introduced the Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (Clear Labels Act), which “would require prescription drug labeling to disclose the original manufacturers of generic drugs and APIs, giving patients, providers, and regulators clear, upfront information about a drug’s origins.” According to his website […]
After all these years of skinny-label suits, the issue is finally going to be adjudicated through the top court in the land. Remember that the Supreme Court previously refused to review a skinny label case (here). We’ve written ad nauseum (search the Lachman blog here for hours of reading) about the skinny label, which permits […]
Typically, when the FDA issues a labeling safety warning, it means that a new warning is being added to existing labeling. However, in an FDA safety notice published today titled FDA Requests Removal of Suicidal Behavior and Ideation [SI/B] Warning from Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) Medications (here), the FDA is advising GLP-1 RA […]
The newly issued revised and finalized “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers: Guidance for Industry” (here) does not differ much from the previous draft guidance of the same title issued on April 25, 2024 (89 FR 31757). The final guidance was revised to incorporate comments […]
