In November 2025 the FDA requested that manufacturers of hormonal treatments for menopausal symptoms make changes to the labeling to remove boxed warnings about a probable risk of breast cancer, cardiovascular disease, and probable dementia because new information evaluated by the Agency has made those warnings obsolete. These changes in labeling have had a dramatic […]
The Federal Register pre-publication notice published today (here) lists Etomidate as a product with possible abuse potential that will be reviewed for scheduling under the Controlled Substances Act. It is a short-acting anesthetic and mentioned often on TV medical shows when a patient is brought into the ER either unresponsive or in need of immediate […]
Today, the FDA issued the final guidance titled Evaluation of Therapeutic Equivalence (here). The guidance is essentially identical to one with the same title issued in July 2022. There are only a few changes from the draft guidance, which include revisions to reflect an additional process by which applicants of certain 505(b)(2) applications may request […]
Keep an eye on your mailbox and get ready to open your checkbook! FDA says: “The annual FY 2027 PDUFA program fee invoices were emailed on Tuesday, August 18, 2026. Please note that the invoices are only sent to firms with PDUFA user fee eligible products. If you do not receive your FY 2027 program […]
Today, the FDA has published revision 1 (here) of the draft guidance Determining Whether to Submit an NDA or a 505(b)(2) Application issued in May 2019. Its purpose is to further define which abbreviated pathway, ANDA, or a 505(b)(2) application, is the appropriate submission type for the market application. The guidance first defines what a […]
The Agency has issued a 37-page draft guidance (here), that describes FDA’s current thinking regarding a wide range of issues regarding various container closure systems, packaging components and testing requirements to ensure that the proposed container closure system is appropriate for the proposed drug product. FDA says that when finalized, this draft guidance will “supersede […]
The announcement in the prepublication of the Federal Register of the new FY 2027 PDUFA user fees for NDAs and BLAs might be a bit of a pleasant surprise to sponsors as the decrease in fees is something we usually do not see. Perhaps it is due to the significant staff reductions seen during the […]
Today, the FDA approved a combination of acetaminophen and naproxen sodium tablets, 325 mg/110 mg for minor pain as an over-the-counter product for 12-hour pain relief. FDA says in a press release (here): “This nonprescription product is indicated for the temporary relief of minor aches and pains due to headache, backache, muscular aches, toothache, menstrual […]
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 pharmaceutical supply chain is no longer just a chain of physical materials, but rather a complex series of data, data-based decisions, and delegated responsibilities for that data. FDA’s CDER FY2024 Site Catalog reported 4,619 manufacturing sites globally, reflecting the broad scale of the regulated manufacturing network supporting the U.S. drug supply. Within that network, […]
