For many years, innovators have used the petition process to gum up ANDA and 505(b)(2) approval process and hopefully delay FDA clearance of such applications. Because of this problem, Congress was compelled to pass legislation (the Food and Drug Administration Administration Act [FDAAA] of 2007) to help correct this unintentional impact on generic drug, 505(b)(2) NDAs, […]
Our blog post of August 15, 2016 contained an error. What we meant to convey was that unless the capsule composition did not change, a PAS was required. We have changed the post to correct this error, and apologize any confusion that this might have caused.
Sponsors are required to submit information in their NDA filings to include “the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be […]
I can’t tell you how many times over my 33-year career that firms have asked me how to submit (or what category of supplement, i.e., Changes being Effected (CBE), CBE-30 or Prior Approval Supplements [PAS]) a capsule supplier change would be. I also have heard from many different firms about what changes were allowed by […]
The Office of Generic Drugs (OGD) released its July approval and ANDA receipt data today (here). So far this FY, OGD has approved 548 original ANDAs or a monthly average of 54.8 (easy to calculate since this is month 10 of the FY). OGD did say there would be good and bad months for approvals […]
Based on the updated numbers for 9 months of 2016 for metrics other than Approvals, Tentative Approvals, receipts of original ANDAs, which were reported on in a previous blog post (here), Office of Generic Drug (OGD) numbers point mostly towards higher numbers. Some metrics have only been reported in the same context for the last […]
The GDUFA Fees for FY 2017 that go into effect October 1, 2016 were published today in the Federal Register (FR) (here). There are some interesting observations relative to the changes in the fees. Original ANDA application and Prior Approval Supplement fees dropped by almost $6,000 and $3000, respectively. While the number of ANDAs submitted […]
The integrity of all GxP data used to ensure the quality and efficacy of drugs is paramount to a drug’s safety and efficacy and can have a great impact on public health. To that point, the MHRA has published a draft version for consultation of a guidance titled “MHRA GxP Data Integrity Definitions and Guidance […]
The issue of sameness of labeling for generic drug products continues to be under scrutiny from both the innovator as well as the law bar. However, from a historical perspective, the concept of carving out certain provisions of labeling covered by exclusivity continues to be an area where the FDA has made only a few […]
The number of Controlled Correspondence (CC) sent to the Office of Generic Drugs (OGD) appears to be rising from year to year since the implementation of GDUFA (see chart below). The numbers in this table were derived from the Activities Report of the Generic Drug Program for the respective Fiscal Years so far under the […]
