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 have reached the halfway mark of June and, as of the unofficial reporting through June 15th,OGD has issued just 24 full approval actions and 7 tentative approval actions. Two ANDAs received partial full approval with at least one other strength receiving tentative approval, likely because of patent or exclusivity issues. The count for the […]
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 Office of Generic Drugs (OGD) filled in the blanks on its April Generic Drugs Program Activities Report – Monthly Performance (here) and here are the highlights of some of the important numbers. OGD issued refuse-to-receive (RTR) to three (3) ANDAs, all of which were for standard review ANDA submissions, while acknowledging seventy (70) new […]
Well, it was May gray, as reported in our previous post (here),as OGD full approval actions plummeted in May to just 45, the lowest this fiscal year and all the way back to June 2019. Tentative approval actions projections for May are 13, bringing the total approval actions for May to 58. That is the […]
The Agency today published four draft guidance documents to assist sponsors to better understand the terms and conditions of certain aspects of the Supply Chain Security Act requirements.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 a Federal Register notice today (here), the FDA blasted the HHS under the previous administration for withdrawing the Unapproved Drug Initiative (UDI), citing misstatements, errors of law, and fundamental untruths in the original Federal Register notice, published on November 25, 2020, titled “Termination of the Food and Drug Administration’s Unapproved Drugs Initiative; Request for […]
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 […]
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. […]
Today, the FDA debuted a new page on their website called Upcoming Product-Specific Guidances for Complex Generic Drug Product Development. Its stated purpose is to provide “information related to upcoming new and revised product-specific guidances (PSGs) to support the development and approval of safe and effective complex generic drug products.” This comes after several public […]
