The U.S. Food and Drug Administration announced that it is taking action to help address a potential supply gap of neonatal starter parenteral nutrition (PN). These products provide essential nutrients through an IV to premature and critically ill newborns who cannot receive nutrition by mouth or through a feeding tube. The FDA has issued an […]
Not the best news (even unofficially), as OGD unofficially issued only 41 full approval actions in August. This represents the lowest monthly number of full approvals in all of FY 2026 to date and with just one month left in this FY, OGD may be scrambling to get more out the door. Although if the […]
We are coming up to the end of another Fiscal Year and the OGD has just 2 months of official stats to report. Here is what Happened in July. OGD approved 68 new ANDAs and issued 18 tentative approval actions in July. Of the 68 newly approved ANDAs, 6 were for first-time generics and 11 […]
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 […]
I read two articles today that made me wonder what the next year will look like for enforcement activity in the compounding arena. First was an article by Peter Pitts published in RealClear Health (here) titled “The Compounding Loophole Has Become a Business Model”. The second is a report in the Pink Sheet written by […]
In an article in the Pink Sheet (here, subscription required) written by Maaisha Osman and Derrick Gingery, titled “US FDA Scraps Program That Paid Bonuses For Completing Speedy Drug Reviews”, the authors note that “[T]he US Food and Drug Administration is scrapping a controversial program that offered bonus payments to drug reviewers who completed their […]
In an article published today on FDA’s webpage (here), the FDA notes that it “is aware of reports of at least 30 patients who experienced adverse events following the administration of intravenous (IV) glutathione alone or in combination with other ingredients”. The problem has been identified as the use of a dietary grade of glutathione […]
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 […]
FDA announced that BsUFA fee invoices were mailed on August 21, 2026 and should be coming to you soon. The Agency reminds sponsors that if you are expecting an invoice and do not receive it, please contact the BsUFA User Fee staff at FDAUserFees@fda.hhs.gov. Payment is due on October 1, 2026. As a reminder, the […]
Today, the FDA published 55 product specific guidances (PSGs) that provide FDA’s current bioequivalence recommendations for generic products. The PSGs can be found here and the current listing represents 24 new and 31 revised PSGs. FDA says that today’s batch of 55 PSGs contain: More than 30 for products with no approved ANDAs including 15 […]
