There have been eighty-six first-time generic approvals for the calendar year 2019 thus far, at least through November 8, 2019, according to the updated list by the FDA (here). The FDA wants us to remember that first approvals do not always translate into products that are immediately available to the public due to either patent issues,
On Wednesday afternoon at AAM’s GRx+Biosimilars Conference in Bethesda, MD, the FDA held a valuable workshop on Complex Generic Drug Products. The workshop opened with a general session explaining the opportunities for interacting with the FDA to get guidance and input while developing your complex generic and preparing your ANDA and how to get the most out of these interactions.
On the last day of at the Association for Accessible Medicines GRx-Biosims conference in Bethesda, members of the FDA joined industry for an informative and interactive discussion on post-approval supplements. Dr. Paul Schwartz and his colleague Olugbenga Okubadejo expressed satisfaction with the current state of the post-approval supplement process, as well as the example of teamwork it has taken to get it there (both within the FDA and also in partnership with industry).
An interesting session during the GRx+Biosims conference held in Bethesda on November 4, 2019 addressed Drug Substance and Drug Product Manufacturers – Partnering to Improve the Process. The presentations from the FDA, as well as industry, acknowledged that the adequacy of drug master files (DMFs) for APIs in one cycle has been a lot more challenging compared to that of the first-cycle approval of ANDAs.
At the Association for Accessible Medicines GRx-Biosims conference currently ongoing in Bethesda, FDA called on Generic firms to be involved and participate in innovation and FDA’s Emerging Technology initiative. We heard that innovation was not something that should be limited to just Brand Companies. But, in the field of Generics, where Q1/Q2 and sameness or interchangeability is key,
I am pleased to report that the approval and tentative approval actions are again appearing on the daily approvals and All Approvals listing on the FDA website again. So far, it looks like another of the slower months for approval and tentative approval actions to start off the new fiscal year. To date (through October 30),
Today, the FDA issued Revision 1 to the above-referenced guidance. According to the Federal Register notice announcing the availability of the revision, “[T]he draft guidance announced in this notice revises and replaces the draft guidance for industry on ‘Assessing User Fees under the Generic Drug User Fee Amendments of 2017.’ This draft guidance addresses changes in user fee assessments from GDUFA I,
I have recently touched upon the subject of nitrosamines in drug products as part of a blog on Extraneous Peaks. (here) The concern about nitrosamines in drug products continues to grow, and it will be a significant challenge for the regulators and pharmaceutical industry to establish meaningful policies and procedures to ensure there are no safety concerns for marketed products.
In two separate Federal Register (FR) Notices on the FR prepublication page (here and here), the FDA proposed to withdraw approval of two ANDAs based on lack of confidence in the bioequivalence data contained in the applications. The concern relates to a problem at a bioequivalence testing laboratory. The Notices state:
“In May 2010 and December 2010,
Well, another full FY has come and gone and OGD has posted the rest of its FY statistics. Let’s take a look at how this full second year of GDUFA II stacks up with the first year of GDUFA II and journey back a bit to GDUFA I for certain metrics to see what we can see.
The FDA released a final Q&A document titled “Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER: Questions and Answers” that provides answers to some of the most frequently asked and problematic questions raised by incomplete manufacturing, testing, packaging, etc.
The document provides specific guidance on what, where, and how to list such information in the 356h and in the relevant modules of the application.
A new draft guidance titled (quite originally) Drug Master Files (here) has replaced the Drug Master Files: Guidelines that was published in 1989. There have been many changes to the requirements and procedures for DMFs based on new laws, policies, and procedures, as well as procedures associated with GDUFA commitment letters for ANDAs,
For the first time since GDUFA’s beginning, the number of ANDA approval actions exceeded the number of ANDAs received in a given FY (935 approvals vs 909 new ANDA receipts). In addition, OGD smashed the FY approval record with the 935 approval actions by 154 (or 16.5%) more than the previous record of 781 in FY 2018.
August saw the OGD refusing to receive only three applications, one standard application and two priority GDUFA II applications. Quite interestingly, thus far this FY, the number of priority-review applications compared to the number of standard-review ANDAs that have been refused to be received (10/37) is quite high considering that there are many more standard-review applications submitted each month.