Complete Response Letters (CRLs) (remember those letters where FDA was going to respond all at once with Division level review and you were not going to get any more discipline specific letters?) are a harbinger of “approval issues that are too great to resolve through other means”. Yes, that’s right, expect a CRL if issues are complex or too vexing to permit approval.
Partial updates to the Generic Activity Report for FY 2015 were recently published and, while we see a recent surge of approvals, the number of Complete Response Letters (CRLs) issued appears to be flat across all of the first three GDUFA Cohort years.
The Office of Generic Drugs (OGD) is evolving as the GDUFA process is gaining steam, and the pieces are coming together regarding coordination of reviews, and as efficiency in the review and approval process improves. Here are some interesting facts that have come out of OGD
With October 1, 2015 signaling the start of cohort year 4 of the GDUFA program, the receipt and approval numbers are in the book for first three years of the program. Let’s take a look at the numbers to see where we may be heading.
In a Federal Register (FR) Notice today (here) , FDA has indicated that a long-held practice of requiring the submission of actual or printers proof of final printed labeling (FPL) will no longer be required for ANDA approval, and that OGD will accept draft labeling for approval purposes.
The Office of Generic Drugs (OGD) approved 61 ANDAs in the month of September to close out fiscal year (FY) 2015 on a high note.
The FDA is required to produce a yearly report that addresses the number of petitions filed during the previous year, the number of those petitions that were designated as 505(q) petitions, and the number of the 505(q) petitions that delayed whether a 505(b)(2) application, ANDA or biosimilar approval. The FDA report (here) indicates that, […]
FDA approved the first 3D printed drug product on August 3, 2015. The product, named Spritam (levetriacetam) is used to treat seizures. The product is listed in approved labeling as a “tablet for oral use.” Interesting terms for this new dosage form
Well, as someone who routinely reviews regulations.gov postings from the FDA, this comes as a bit of a surprise, because on some docket items there are literally thousands of comments to sift through. Turns out that a pre-publication Federal Register notice (here) released today indicated that, back in 2007 when FDA merged its postings to […]
Late last week, the Generic Pharmaceutical Association posted its comments (here) on the final Guidance for Industry – Size, Shape and Other Physical Attributes of Generic Tablets and Capsules (here). GPhA questions whether OGD has the statutory and regulatory authority to enforce this Guidance. There is a nice posting from our friends at the […]
