The voucher program for rare pediatric diseases and tropical diseases was established to encourage firms to develop drug products for both of these categories. The voucher is awarded when such an NDA is approved, and that voucher can be used on another NDA by the same company or transferred (sold) to a third party to use on any other NDA products.
OGD updated its Activities Report of the Generic Drug Program on Tuesday and there are not a lot of surprises to the updated numbers (we reported on the approvals, complete response letters, and receipts for August here.
Really the only things of interest appear to be the number of CBE supplements,
In a CDER Conversation piece entitled Patents and Exclusivities for Generic Drugs, Captain Martin Shimer, Deputy Direction, Division of Legal and Program Support, Office of Generic Drugs (OGD), briefly outlines various issues with patents, patent certifications and describes that various types of exclusivity that must be dealt with.
Patents are pretty straight forward,
The new Commissioner of FDA, Scott Gottlieb, M.D., has been moving very quickly since assuming his post. In a recent announcement reported by RAPS in its Regulatory Focus (here), he indicated FDA’s upcoming plans to “begin releasing letters that FDA sends to brand drug companies when generics question the agency on whether they should be able to obtain samples of the brand drugs necessary to produce generic versions.”
Many of these drugs are provided to patients through restricted distribution programs in which the drugs are sent from a specialty pharmacy directly to the patient.
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 1,
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 Letters (CRLS) where OGD reported the issuance of 155 CRLs,
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) 16 ANDAs for a total approvals action of 73,
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 of deficiencies that will result in an RTR action,
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 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 5-year GDUFA I period was just over 1000 ANDAs.
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 should be based upon a thorough process which is defined within the procedure.
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).
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 reviews,
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 full guidance here).
With an approval surge in the last few days of July 2017, the Office of Generic Drugs (OGD) managed to fully approve 68 ANDAs and tentatively (TA) approve 14 ANDAs for an approval total for July of 82. Complete Responses tumbled to their lowest for most of GDUFA I at 81, clearly the lowest of the FY.