Remember when GDUFA I first started and there was a huge number of ANDAs submitted prior to the October 1 implementation date to avoid paying the ANDA fee? Remember when OGD changed its stability requirement in June 2014 and there were 635 ANDAs submitted prior to the implementation of the new stability requirements? Well, October […]
We were close with our September 6th post (guess) but there were a few more approval actions reported in the official statistics that were released Friday September 8 in the afternoon. OGD approved 60 ANDAs and tentatively approved 17 ANDAs for a total approvals action of 77. There was also a spike in Complete Response […]
Looking at the FDA’s “All Approvals” list (here) and slugging through supplements and originals for both ANDAs and NDAs, it looks like OGD efforts in August will yield about 57 approvals (the 7th lowest so far in the first 11 months of FY 2017). Also, though OGD tentatively approved (what looks to be like) […]
Friday, September 1, 2017, the FDA issued MaPP 5200.14, a 43-page document that describes the Office of Generic Drugs’ internal policy and procedures for evaluating an ANDA for initial receipt as substantially complete for “receipt” (filing) purposes. We previously posted about this document here. The MaPP also outlines the Refuse-to-Receive (RTR) limit on the types […]
On August 30, 2017, the FDA responded to three older petitions all submitted by the same law firm relative to Digoxin products. See FDA’s full response here. The petitions addressed three basic issues: 1) 3-year Hatch-Waxman exclusivity; 2) bioequivalence requirements for this narrow therapeutic index drug; and 3) dissolution and blend uniformity requirements. The petitions […]
The generic drug user fees for year 1 of GDUFA II have been announced by FDA. There are 2 fundamental differences in the GDUFA II fee structure relative to GDUFA I. First, GDUFA I was built on the assumption of OGD receiving about 750 ANDAs per year. The average number of ANDAs received over the […]
The ISPE has issued a GAMP: Records and Data Integrity guide which provides principles and practical guidance on meeting current expectations for the management of GxP regulated records and data, ensuring that they are complete, consistent, secure, accurate and available throughout their lifecycle. A critical component of the data lifecycle is Data Review. Data review […]
On Friday. the Office of Generic Drugs released an updated version of its workload charts (here). Two of the charts are displayed below with explanation. Total Original ANDA Workload Activity for Pre-GDUFA Year 3 Application Cohorts Thru 7/1/2017 This chart shows all pre-GDUFA year three applications (those before goal dates were assigned). There are 1,105 […]
During the Hatch-Waxman meeting recently held at FDA headquarters, the new Commissioner alluded to two documents that he pledged would be issued hopefully by the end of this year. One was a Good ANDA Assessment MaPP and the other a Good ANDA review Practices document. In reviewing the history of the industry complaints regarding inconsistent […]
For those of us that have been around a while and are well versed in the FDA’s expectations on repackaging of solid oral dosage forms into unit dose (UD) packaging, there is really nothing new in the recently published Guidance for Industry – Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products. (see […]
