I cringed while reading the opening two paragraphs of the article (here) written by Lawrence J. McQuillan in The Hill titled “How a reformed FDA can speed up delivery of lifesaving drugs”: The Biden administration favors a proposal to waive patent protections for the COVID-19 vaccines. But there are other ways to remove impediments to […]
For the last 5 or so years, the FDA has told applicants that they could likely submit an ANDA for a synthetic peptide product (40 amino acid chains or fewer) when the reference listed drug (RLD) was of rDNA origin but the guidance on which products, how, and what would be required was often sketchy. […]
Just nine (9) days ago, I posted a blog and article (here) on the issue of paper prescribing information – package inserts! The overall takeaway was that FDA is ready to move on this issue. There was a proposed rule sitting dormant, because every year since its proposal, e Congress has included a provision in […]
While there still may be a few more stragglers that have not yet hit the FDA’s “All Approvals List” as of May 6, 2021 (here), we will catch them when the OGD releases its official numbers for April sometime in the next two weeks. The total for full- and tentative-approval actions reported was 71 which, if […]
Starting at the crack of dawn for us west coasters, today’s meeting kicked off with three presentations on application issues: mid-cycle meeting overview; information to include in cover letters; and application communications – quality perspectives. Lots of information was presented and highlights are discussed below. Mid-cycle reviews are reserved for complex generics and may also […]
The afternoon started out with a discussion of Biopharmaceutics Risk Assessment to Guide Dissolution Method Development for Solid Oral Dosage Forms. The presentation provided an introduction to the understanding of the purpose of biopharmaceutics risk assessment and a discussion of how to perform the assessment which focused on understanding the role of in vitro dissolution […]
The afternoon sessions of FDA’s Generic Drug Forum on April 28, 2021 were very information-intense and provided a significant amount of review information and suggestions for success in ANDA submission and approval. Caliope Sarago, Senior Regulatory Health Project Manager, Office of Research and Standards, Office of Generic Drugs, gave a comprehensive review of the pre-ANDA […]
An article in STAT (here) (paid subscription required), authored by a former FDAer, Jane Axelrad, should be read by all in the pharmaceutical industry. Axelrad notes that, while online access to current prescribing information has been available for over fifteen years, progress in eliminating the requirement to provide paper labels has been stymied by paper […]
Yesterday, the FDA issued a long-awaited guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency (here). The guidance notes that the Agency will determine whether remote inspections will occur and which tools are appropriate as alternatives to on-site inspections but indicates that it will not accept […]
Ricki A. Chase, M.S, Lachman Consultants, wrote a recent article for Contract Pharma looking at the benefits and challenges of the trend towards combination products. Here is a brief excerpt from the article: “As the life sciences industries have continued to evolve, the need for ever changing nomenclature has evolved along with it. It was […]
