Happy July 9th! Hope you had a great Fourth of July weekend, but now it’s time to get back to business. The OGD seems to have squeaked by its lowest month totals of approval actions this FY (for May) as it appears to have recorded sixty total-approval actions for June, at least through the July […]
The last post we did on this list was back in June 2020 (here ) and there were 269 products on Part I (those that firms can immediately submit an ANDA) and 136 on Part II (those products that may be more difficult and present various regulatory or scientific issues and for which FDA recommends […]
We last posted on Competitive Generic Therapy (CGT) approvals in the beginning of April (here) when the Office of Generic Drugs reported 80 approvals for CGT ANDAs. In its latest report (here), that number has jumped to 90, with the approval of ten (10) additional ANDAs approved through the CGT program. Of the ten (10) […]
The Agency today published four draft guidance documents to assist sponsors to better understand the terms and conditions of certain aspects of the Supply Chain Security Act requirements. The draft and final guidances are as follows: Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act – This […]
In Southern California, May is noted as a month that sees a usual marine layer hanging over the coast. They call it “May Gray”. June is not much better and has the adopted the moniker of “June Gloom”. We often get sunshine later in the day, but most mornings are a combination of low clouds […]
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 […]
