A day or so ago, the FDA released Manual of Policy and Procedure (MaPP) 5021.5 titled Assessment of Facility‑Based Deficiency Major‑to‑Minor Reclassification Requests. A MaPP is a document that informs how the FDA will handle, manage, and prosecute a particular issue internally. In this case, it describes how the FDA will adjudicate a request to […]
How do you stop a drug shortage? Make it profitable for more than one, two, or even ten generic companies to sell the drug. History has shown that when five (5) or more players enter a generic field, the drug price drops substantially. Have more than 5-7 players – the price drops to 80% of […]
A few days ago, the FDA published a guidance document titled Cover Letter Attachments for Controlled Correspondence and ANDA Submissions (see here) that describes three checklist attachments for various types of ANDAs and related submissions. The checklists are identified as being voluntary, but the OGD suggests that not only can they aid applicants in ensuring […]
OGD published its official statistical report for April 2023 today (here) and we hit the nail on the head with our prediction of the number of full approval actions at 64 but we missed by one on the tentative approvals actions where we reported 11 (see previous post here), but there were actually 10 in […]
In the generic drug business, most times it is best to be first! This means trying to be first in development, submission, and (of course) approval. But, in order to have a chance of being first, you must know what to do, and that is especially true of knowing what the bioequivalence (BE) requirements are. […]
A Citizen Petition submitted recently by McDermott Will & Emory (here) on behalf of Vanda Pharmaceuticals requests that the FDA “revoke approval of Abbreviated New Drug Application (ANDA) No. 211654, submitted by MSN Pharmaceuticals Inc. (MSN), for 20 mg tasimelteon capsules, and order a recall of any product that has been distributed under ANDA No. 211654 (if any) […]
Today, the FDA released another batch of Product‑Specific Guidances (PSGs), outlining its current thinking on the bioequivalence (BE) testing requirements for generic products – twenty‑five new BE guidances and twenty‑one revised guidances. The listing can be found here. The FDA has various goals regarding publication of these PSGs that are tied to getting information to […]
With the generic product approvals currently listed through May 15th on the All Approvals website (here), OGD has issued 30 full approval actions and 10 tentative approval actions for the month of May so far. Hopefully this will bode well for total approvals for the full month. We do have a major holiday coming up […]
Yahoo News reported this morning (here) that the Supreme Court refused to wade into the waters of the skinny label case regarding the Teva V GSK case. We have written extensively about the skinny label issue (here, here, here, here, , here, here, here here, and here. That’s a lot of discussion, but this is […]
Coming off the March total of 117 (ninety‑six full approvals and twenty‑one tentative approvals), April’s numbers are good but fall short of any big records. April saw the OGD unofficially issue sixty‑four full‑approval actions and eleven tentative‑approval actions for a total of seventy‑five approval actions. If these figures hold firm when the official numbers are […]
