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.
Looks like FDA is nearing the end of the daunting task of developing and (soon hopefully) publishing a “Difficult to Compound List” that has been in the works for nearly 17 years. At a meeting on July 13 and 14, 2000, an advisory committee on compounding (specifically, the Pharmacy Compounding Advisory Committee [PCAC]) provided FDA advice about the Agency’s efforts to develop a list of drugs that present demonstrable difficulties for compounding under section 503A of the FD&C Act (version in effect in 2000).
The question of where, when, and how to label a product, whether it be a prescription drug, OTC product under an approved application, or an OTC product marketed under the monograph system has always been kind of a guessing game for manufacturers, packagers, and repackagers. Now, a new Guidance titled “Child-Resistant Packaging Statements in Drug Product Labeling” answers many of those questions and provides guidance as to how to be in compliance with the FDA regulatory scheme.
FDA was hoping to have the User Fee Bill passed and to begin work on publishing fees and the accompanying Federal Register Notices that must go out ahead of the September 30 expiration of the funding measures. Remember, FDA must have legislation in place in order to request the fees, collect the fees, and spend the new money that comes in for the fees.
The Office of Generic Drugs’ update to the Activities Report of the Generic Drug Program for June 2017 (here) lists 6 Refuse-to-Receive (RTR) actions, the lowest for any moth this fiscal year. As a matter of fact, it is the lowest number of RTR actions since early in the GDUFA days when,
To date, according to the FDA All Approvals report (here), so far this month there have been 54 recorded full approvals and 11 tentative approvals. Of course, we have today, July 31, not yet reported and there will be a few posting of approvals over the last 2-3 work days, but,
The FDA today, in the Federal Register, announced a public workshop to be held on September 12, 2017 to discuss the use of real world data (RWD) and real world evidence (RWE) in its regulatory decision making process. The workshop, titled, “Developing a Framework for Regulatory Use of Real-World Evidence”, will be held in Washington DC.
Today, OGD released an updated version of a Q&A document entitled, “Generic Drug User Fee Amendments of 2012: Questions and Answers: Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance”. This document provides FDA responses to many questions that have been raised by industry during the administration of GDUFA I.
The controversial rule that would “amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license application (BLAs) to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA’s review of such change” has shifted to long-term actions on the HHS unified agenda (here).
Back in May 2016, I wrote a blog post (here) about a budgeting proposal put forth by Senator Joe Manchin of West Virginia that would have financed opioid treatment programs by a tax on the opioids themselves. This would eventually have placed higher purchase costs on the patients that needed the drugs.