In an announcement today, the FDA has explained its decision to revise the labeling of hormone replacement therapy (HRT) products based on reevaluation of older studies in light of new data. The FDA recognizes a difference between the risks associated with oral HRT products vs. vaginally applied HRT products and the labeling changes reflect this […]
FDA announced a new revised draft guidance which “is being updated and reissued in draft to, among other things, include the addition of information related to Congress’ 2018 changes to the definition of adverse drug experience regarding reduced effectiveness and make other changes to reflect current Agency processes and procedures regarding safety labeling changes. This […]
Yesterday, the FDA published information on a new Limitation of Use statement required for extended-release ADHD drugs (here). Specifically, this class of drug has been shown to be associated with greater risk of significant weight loss and other side effects in children 6 years of age or younger “than older children taking the same medication at […]
On June 25, 2025, Reps. Sherrill and Harshbarger reintroduced a bipartisan bill to modernize prescription information (here) and, on June 12, 2025, two senators introduced a similar bill in the Senate (see previous post here). Now we have very similar bills floating around in each chamber. Maybe this is the year that the legislation will pass […]
Yesterday, U.S. Senators Markwayne Mullin (R-OK) and Cory Booker (D-NJ) reintroduced the “Prescription Information Modernization Act of 2025.” You’ll likely remember that it has had quite a history. It’s a commonsense bill that would allow firms to use electronic labeling, eliminating the requirement to include paper package inserts, better known as the prescribing information, while […]
Yesterday, the FDA issued a draft guidance titled “Replacing Color Additives in Approved or Marketed Drug Products” (here). We all know that removing or partially removing a color from a product was an easy annual reportable change, and this remains unchanged in the draft guidance. However, changing a color by replacing it with another color […]
As a refresher, a reference listed drug (RLD) product for which sale has been discontinued or for which the firm has withdrawn its approval for commercial reasons and that was relied upon as the basis for submission of an ANDA creates a regulatory problem for firms that have approved ANDA versions or drug products with […]
In a pre-publication notice in the Federal Register today (here), the decision on the issuance of the rule will be kicked down the road another sixty days until May 21, 2025 so the FDA/administration can fully vet the rule. This is the second delay since it was published as “a final rule, titled ‘Nonprescription Drug Product […]
For those of you that have been following the saga of the attack on the skinny label, we may be getting close to a solution. Remember that a skinny label is labeling that cuts out a particular use or information protected by patent or market exclusivity of the branded product. This allows for a generic […]
Just a week or so ago, there was a significant concern raised regarding the use of buprenorphine in chronic opioid use disorder (OUD) and the development of severe dental caries that occurred in a number of patients who previously had no history of increased caries prior to the start of therapy for OUD (see here). […]
