Tuesday’s session of the Fiscal Year (FY) 2022 Generic Drug Science and Research Initiatives Public Workshop opened with a presentation by Michael Banks, Senior Vice President, Global Head Regulatory Affairs, Teva Pharmaceuticals discussing the global challenges to the development of complex generic drugs. Dr. Banks challenged the regulatory bodies to move towards more standardized approaches […]
The FY 2022 Generic Drug Science and Research Initiatives Public Workshop held May 9-10, 2022, addressed a significant number of complex drug product questions as well as feedback from the industry as to what steps would be helpful for FDA to undertake to facilitate complex product development, review, and approval. With GDUFA III considered to […]
In a previous blog post (here), we discussed the results of an April 16, 2021 decision by the U.S. Court of Appeals for the District of Columbia Circuit in Genus Med. Techs., LLC v. FDA, 2021 (U.S. App. Lexis 10928 [April 16, 2021]) which the FDA decided not to appeal. This court decision dealt with […]
Yesterday, the Agency expressed confidence that manufacturers of varenicline tablets containing the N‑nitroso-varenicline impurity can meet the FDA’s original acceptable intake limit of 37 ng or less per day. Their statement read: “FDA is now confident in manufacturers’ ability to supply patients with varenicline containing the N-nitroso-varenicline impurity at or below the agency’s acceptable intake limit […]
The March statistical update to the Generic Drugs Program Activities Report – Monthly Performance brings the refuse-to-receive (RTR) count back to a manageable number of three, which has been seen every month so far this FY except for last month, which saw triple that number. The OGD also acknowledged sixty‑two ANDAs in March. Other metrics […]
At the Generic Drug Forum virtual SBIA event that is still ongoing, Andrew J. Fine, PharmD, BCPS, Senior Advisor, Division of Clinical Review, Office of Safety & Clinical Evaluation, Office of Generic Drugs, provided a look at the type of information that needs to accompany a complex product (particularly a drug device combination) to establish […]
According to the Activities Report of the Generic Drugs Program | GDUFA II Quarterly Performance published yesterday, the Office of Generic Drugs is looking at over 1,712 ANDAs that are pending Agency action. While down a bit from the 1,749 reported at the end of the first quarter, the number jumped from the end of […]
April showers bring May flowers, as the saying goes. Well, April thus far has not showered down approvals as, halfway through the month, the OGD stands at twenty‑one full‑approval actions and three tentative‑approval actions. If the trend continues through the end of the month, we could be heading for a month with less than fifty […]
The OGD updated its usual February statistical report late yesterday (April 18, 2022) to complete the month’s reporting. To start out with a bit of a startling number, February saw nine ANDAs issued refuse‑to‑receive (RTR) letters. This is triple the number in any month this FY (only three RTRs were reported in each of the […]
Today, the FDA published the final guidance titled “Bioavailability Studies Submitted in NDAs or INDs — General Considerations” (here). The final guidance comes after the FDA incorporated comments that it received on the draft of the same name issued on February 26, 2019. That 2019 draft guidance replaced the March 2014 guidance titled “Bioavailability and Bioequivalence Studies […]
