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). […]
The Generic Drug Cluster is a consortium of top regulatory agencies from around the world that get together to discuss common issues related to the drug approval process in an effort to better understand how each agency approaches various topics. Hopefully, these discussions will result in developing regulatory strategies that reflect the best and most […]
For those of you who follow the daily approvals page (here), on November 21, 2024, there was a flurry of supplemental labeling approvals listed for drug products that contain non-steroidal anti-inflammatory drugs (NSAIDs), from aspirin to Zipsor (diclofenac potassium). In today’s CDER Drug Safety-related Labeling Changes (SrLC), the new, revised warning that must be included was […]
We have written extensively about the attack on the section viii label carve-out that is permitted under the Hatch-Waxman Act (H-W); this carve-out allows certain changes to a generic drug’s labeling to avoid patent infringement or certain exclusivity protection (here, here, here, here, and here). This so-called section viii label carve-out was part of the delicate balance […]
The FDA has just revised a guidance titled, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers” (here) which says: “This revised draft guidance, when finalized, will describe FDA’s current thinking on common questions firms may have when voluntarily addressing misinformation about or related to their approved/cleared medical products. This guidance revises and […]
The Association of Accessible Medicines (AAM) and the BioSimilars Council (a Division of AAM) released a statement of support (here) for a legislative fix to provide a safe harbor for generic / biosimilar label carve-outs. The issue is the potential threat of litigation for inducement to infringe, a problem that could bankrupt a generic or […]
This morning, I was reading an article written by Sally Turner in Pharmaceutical Technology (here), suggesting that the FDA take a greater role in the review and validation of the patents that brand-name companies list in the Orange Book (OB). She addresses the Hatch-Waxman Act’s patent listing provisions and discusses other views held on the […]
Today, the FDA has published a new draft guidance titled Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDA (here) that describes the FDA’s current thinking on consistency of composition statements in NDAs and ANDAs. It provides a clear and unambiguous requirement to list both the qualitative […]
