“Disruption” was the common theme expressed by many panel members at this year’s Access 2025 meeting of the Association for Accessible Medicines in Amelia Island, Florida. In speaking to attendees, “I just don’t know what to expect” seemed to be the mantra of the day. The absence of FDA attendees also seemed to shake the […]
The OGD is off to a good start in 2025, with 31 full-approval actions and 14 tentative-approval actions for a total of 45 approval actions posted as of January 16. While this number is not as high as the number of Executive Orders signed by Trump in his first day back in office, if the […]
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 […]
In the latest CDER Science Spotlights, available (here), the FDA provides some insight into the development of the Carcinogenic Potency Categorization Approach (CPCA) to determine recommended acceptable intake limits of N-nitrosamine impurities in drug products. The latest revision of the Nitrosamine Impurity guidance updated in September 2024 (here) provided better integration of the overall assessment […]
The OGD published the second month of the Fiscal Year (FY) 2025 statistical report titled, Generic Drugs Program Monthly and Quarterly Activities Report (here). There is some continued good news and also some troubling news in the report. On the positive side, we previously reported (here) in our unofficial posting, the full approval actions as […]
The Code of Federal Regulations at 211.110 is titled “Sampling and testing of in-process materials and drug products.” This new draft guidance, issued by the FDA, is designed to assist drug product manufacturers in complying with this section of the regulations “to ensure batch uniformity and drug product integrity. In addition, this guidance discusses related […]
Twice a year, the FDA publishes an update of the List of Off‑Patent, Off‑Exclusivity Drugs without an Approved Generic (see the December 2024 listing here). This list is designed to generate interest from the industry in increasing competition among such products and it is made up of two parts. Part I is for drugs for which […]
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 […]
The Association for Accessible Medicines (AAM) recently mentioned a report titled “Study: 57 Percent of Covered Generic Drugs Not on Part D Generic Tiers in 2025” (here), conducted by Avalere, that raises serious questions regarding the Centers for Medicare and Medicaid Services (CMS) placement of many generic drugs on higher tiers, which are usually reserved for brand-name […]
According to the first FY 2025 Generic Drugs Program Monthly and Quarterly Activities Report (here), the OGD had a good month for approval actions, issuing 62 full-approval actions and 20 tentative-approval actions for a total of 82. Only one month in FY 2024 had a higher combined total for these two metrics. That’s the good news! The […]
