Don’t blink – things can change in a minute, or at least in one day. After our blog post yesterday on mid-month approval actions for the OGD, a flurry of activity occurred in the postings from a few days past. The new mid-month approval actions can now be reported as 38 full-approval actions (that’s 12 […]
In our June 25,2025 blog post (here), we expressed hope that drug prescribing paper inserts might give way to electronic labeling: “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 […]
There are two federal holidays, Veterans Day and Thanksgiving, in November, making it a crazy month. Lots of Agency staff take vacation around the two holidays, and Thanksgiving week is particularly laden with staff vacation days, which is little surprise as it is one of the busiest travel times for everyone in the U.S. Despite […]
The Office of Generic Drug has published the newly revised Manual of Policy and Procedures (MaPP) 5016.8 titled Using Four-Part Harmony in Quality-Related Assessment Communications (here). The-Four Part Harmony assessment is used in several of the Agency’s Centers and its goal is to promote communication clarity between reviewers and applicants. It also answers the questions of […]
This blog is another in a series providing an analysis of legislative initiatives that may impact your business. Q4 is the time of year when many pharmaceutical companies scan the horizon and develop their enterprise risk assessments and mitigation plans, which should trigger a review of these initiatives. The Economic Crime and Corporate Transparency Act […]
The OGD got back to business right away after the government reopened by publishing the final guidance titled Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use: Guidance for Industry (here). The issue of changing pH-adjuster ingredients for the purposes of creating a generic formulation of […]
Even after he originally said that he wasn’t interested in the job, Richard Padzur, M.D., a long-time (26-year!) veteran of the FDA, was named Director of the Center for Drug Evaluation and Research. As the founding director of the FDA’s Oncology Center of Excellence and in his tenure leading the Oncology Division, Dr. Padzur has been […]
In the FDA-regulated industry, speaking up is a cornerstone of a mature quality culture. It refers to the reporting of deviations, risks, concerns, or unethical practices, whether related to product development, manufacturing, data integrity, or patient safety. When embedded in an organization, speaking up inherently increases detection of signals that are directly or indirectly indicators […]
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 […]
It is no small task to get a guidance document issued by the FDA in normal operating times but in the face of the longest government shutdown in history, the issuance of 76 PSGs (32 new and 44 revised) is nothing short of amazing. Yesterday, the FDA announced the new and revised guidance documents’ availability […]
