The Office of Generic Drugs updated its Generic Drugs Program Activities Report – Monthly Performance for January (here) to fill in more data on various metrics. As you know, the Agency typically comes out with the number of ANDA approval and tentative-approval actions and receipts of original ANDAs, along with the number of complete response […]
FDA has proposed some relief from the component shortages created for parenteral and other products identified in the just released Guidance entitled, COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers. The Agency has recognized the need to provide some regulatory flexibility regarding the filing type for certain changes that may be necessitated […]
On January 14, 2020, we posted a blog (here) concerning a Drug Safety Communication discussing FDA’s concern that the drug product Belviq or Belviq XR (lorcaserin) could increase the risk of cancer. On September 16, 2020, we posted a blog noting FDA’s final action withdrawing the 2 NDA drug applications for the product mentioned above […]
OGD released its official numbers for approval actions, complete response letters and ANDA original receipts for January today, as well as updating metrics for December 2020. From our unofficial numbers reported for January, we hit the numbers of full approval actions on the nose at 62, but OGD snuck in an additional tentative approval action […]
We are two-thirds through the reporting workdays for the month of January 2021 and OGD has reported 35 full approval actions and 4 tentative approval actions (total 39). If the pace of approvals does not pick up in the last 6 reporting days, we are set to have a total of full and tentative approval […]
The confusion regarding the initial publication of the OTC User Fee Act announcing the user fee structure originally published here and its subsequent withdrawal published here is (for the most part) clarified now by the January 12, 2021 FR Notice here that identifies the issue precipitating in the withdrawal. In the current FR Notice, the […]
FDA’s ability to conduct on-site inspections has been significantly impacted by the COVID-19 pandemic. While the FDA is looking and utilizing alternate methods to conduct such inspections when needed, some of the alternate methods are, at least, as time-consuming as actual on-site inspections. Because of this issue and the Agency’s goal of being transparent, they […]
Well, the holiday season may produce a “December to remember”, to quote a car manufacturer’s favorite tag line at this time of year. What we don’t know is will it be good to remember or not so much. December usually is one of the highest months for approval actions with the last three Decembers producing […]
Unofficially, it appears that FY 2021 is being kicked off by the highest number of approval actions in the last eighteen months. That’s right, it looks like the OGD will hit a total of at least ninety approval actions for October, which consist of at least seventy-seven full-approval actions and thirteen tentative-approval actions. Why do […]
Did you ever wonder about the FDA’s requirement than an applicant respond to a complete response letter (CRL) within one year of its issuance as provided for in the regulations at 21 CFR 314.110? Under this regulation, “an applicant must (1) resubmit its ANDA (i.e., submit all materials needed to fully address all deficiencies identified […]
