OGD updated its Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance (here) on Wednesday, giving us a look at some additional metrics for the month of August. For all the talk of Refuse-to-Receive (RTR) actions, OGD issued only seven (7) in August. Four (4) were for standard ANDAs and three (3) were for […]
Despite a slow start to FY 2018 due, in most part, to the elemental impurities issue, the Office of Generic Drugs (OGD) has broken the FY record for number of approvals. We are not quite sure by how much just yet because the numbers can continue to roll in over the next few days, but […]
On Thursday (September 20th), the FDA held a meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee to discuss the Agency’s plans for implementation of the Knowledge‑aided Assessment and Structured Application program (KASA). The FDA presented to the Advisory Committee two primary goals of the KASA program. On the one hand, it is intended […]
The FDA has updated and finalized its guidance “ANDA Submissions – Content and Format” (here). The 38-page document goes into even more detail than the previous drafts and provides expanded explanations for certain sections and requirements for documents. There is advice for each eCTD section and even an expanded Cover Sheet format suggested in Appendix […]
This morning I read Zach Brennan’s post on RAPS, titled FDA Smashes Record for Most ANDA Complete Responses Letters (CRLs) in One Year (here ). In his piece, he wrote: But the gap between this year and years past – 2,515 complete responses have been issued so far in 2018 vs. 1,603 in FY 2017 […]
The FDA has announced a proposed rule to repeal its regulation requiring any drug product that uses irradiation to be approved under an NDA or ANDA. The Notice states that “this action is part of FDA’s implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify […]
The Office of Generic Drugs (OGD) released its official approval and receipt numbers late yesterday. August saw 53 full approvals and 15 tentative approvals, leaving OGD 44 ANDA full approvals away from matching their previous FY record of 763 from FY 2017. These approvals are quite an accomplishment given the fact that the slowdown in […]
The Complex Generic Drug Development Workshop is currently being held in Silver Spring, Maryland September 12‑13, 2018. In her keynote address at the FDA’s Small Business and Industry Assistance (SBIA) workshop on complex generic drug development, Kathleen Cook Uhl stated that complex drug products are critical to the care of many serious medical conditions, such as […]
The GRx+Biosims Conference held at Baltimore, MD from September 5-7, had a panel discussion regarding Successfully Managing Priority Generic Submissions on September 6th. The panel members were representatives from the industry. Discussions centered around the experience with priority submissions in the first year of GDUFA II. The consensus was that the submission of PFC (pre-submission […]
