In the prepublication of the Federal Register this morning, the FDA announced the Animal Drug User Fee Rates (here) and the Animal Generic Drug User Fee Rates (here). Some of the fees increased significantly while others decreased. Fee variations are based on the projected number of applications, establishments, and products, as well as inflationary calculations. […]
For years, the FDA has been concerned about running out of numbers for the National Drug Code (NDC) to use to identify drug products. They estimate that their runway for exhausting all NDC number combinations may come in 10-15 years. Well, FDA published a proposed rule entitled Revising the National Drug Code Format and Drug […]
For each FY quarter, the OGD publishes a series of metrics (as agreed to in the GDUFA II commitment letter) that identify the FDA’s workload by indicating the number of ANDAs awaiting the OGD’s action, including new ANDAs submitted each month, with separate line‑items for tentatively approved (TAed) ANDAs awaiting approval (the FDA’s current ANDA workload) […]
While most of us old timers grew up with Therapeutic Equivalence (TE) after the passage of Hatch-Waxman, the newly released draft guidance on TE (here) should be a good primer or refresher for most interested parties. There may also be some things you did not know, like how a 505(b)(2) application can request a TE […]
The dietary supplement market is notorious for issues associated with the inclusion of not-permitted ingredients in marketed supplements. Kratom is a recent poster child for this issue, but the erectile disfunction and weight loss markets both seem to have extraordinarily bad compliance and enforcement histories. These two disease states comprise the lion’s share of Warning […]
July had some fireworks early in the month, and when the smoke cleared on July 15th, the OGD reported twenty‑nine full‑approval actions and seven tentative‑approval actions (thirty‑six in total). If this pace continues, the OGD should surpass seventy total approval actions again this month. For the nine months already officially in the books, six of […]
When we did our peek at the June Approval numbers mid-month (here), we predicted that June would be a good month and, at the time, indicated that there would likely be approval actions somewhere in the mid-60s. Well, OGD put the push on, and they actually broke the 70 barrier with 71 total approval actions […]
On July 1, OGD updated its monthly statistical report for May 2022 (here). The additional stats (while not particularly remarkable) outline the workload output for the ANDA review and approval process and should be of interest to most of us that pay attention to OGD output. Highlights of the final May statistical report appear below. […]
The breakthrough therapy designation (BTD), once awarded to a drug product under development, triggers a rather intensive use of Agency resources, such as providing “early and frequent advice, conduct multidisciplinary meetings involving senior managers, and when appropriate, expedite the review of resultant marketing applications.” The program is designed to “facilitate and expedite” review of promising […]
The FDA has issued a proposed rule (here) to expand certain new conditions of use for OTC products. When an OTC product is approved through an NDA, it should have all of the necessary information in the Drug Facts section of the label so the consumer can properly select whether the product is appropriate for […]
