“Leaders win through logistics. Vision, sure. Strategy, yes. But when you go to war, you need to have both toilet paper and bullets at the right place at the right time. In other words, you must win through superior logistics.” (Tom Peters – Rule #3: Leadership Is Confusing As Hell, Fast Company, March 2001), from […]
Outsourcing facilties are compounding facilities that are registered by the FDA and subject to inspection. The fee structure is rather simple, with facility fees and reinspection fees only. The fee rates for FY 2023 will go into effect on October 1, 2022. A chart comparing the FY 2022 and FY 2023 fees is provided below: FY 2022 […]
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 […]
Depending on the context, a year can either seem like an eternity or a rather short period of time; the details and context will always matter. In the draft Guidance for Industry issued on July 22nd (here ), the Office of Generic Drugs (OGD) laid out its expectations for complying with the regulatory requirement for […]
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most of us old timers grew up with Therapeutic Equivalence (TE) after the passage of Hatch-Waxman, the newly released draft guidance on TE (here) should be a good primer or refresher for most interested parties.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 […]
With the issuance of draft ICH Quality Guideline ICH Q14 on Analytical Procedure Development (here) and revision of ICH Q2(R2) Guideline on Validation of Analytical Procedures (here), along with the issuance of USP <1220> Analytical Procedure Lifecycle, perhaps it may be time to revisit USP <1058> Analytical Instrument Qualification (AIQ). USP <1058> is a critical chapter providing key guidance on […]
