Earlier this week, the FDA issued a draft Guidance for Industry titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Guidance for Industry” (here). Although the Draft is still out for comments, it gives us a behind-the-scenes look at the FDA’s use of proposed “alternative tools” in conducting remote-based inspections. The proposed Guidance […]
In an alert yesterday from the FDA (here), the Agency indicated that it was changing the TE code of Accord Healthcare’s product (ANDA 091195) from AB (substitutable) to BX (“not sufficient information to demonstrate that Accord Healthcare Inc.’s tacrolimus oral capsules provide the same therapeutic effect as Prograf (tacrolimus) oral capsules”). Tacrolimus is used for […]
Once again, AAM reports the data from the IQVIA 2023 U.S. Generic and Biosimilar Medicines Savings Report (here) which demonstrates the savings power from generic drugs and biosimilars. The Report indicates that, in 2022, the savings realized from the use of generic and biosimilars hit a record $408 billion, of which $9.4 billion was from […]
This is a follow-up to the blog post “Houston, We Have a Problem” (here), noting that, with the exception of the one ANDA approval on September 5, 2023, no other ANDA approvals have been posted to either the Daily Approvals or All Approvals FDA websites through today! As I mentioned in that blog post, this problem […]
If you watch the news at all, you know about this but, more importantly for anyone that has taken phenylephrine, the lack of efficacy should have been very noticeable, especially if you have ever taken pseudoephedrine. The FDA has just issued a statement (here), clarifying the Advisory Committee’s recommendation regarding the lack of efficacy of […]
Today is September 13. 2023. That is not eye-catching news, but the fact that there has only been one ANDA reported as being approved is a bit troubling. We are hoping that this is a recurrence of a glitch in the FDA’s information systems and that ANDA approvals and tentative approvals are just not posting. As […]
Join Lachman Consultants in Washington, DC, Sep 18-20, for the 2023 PDA/FDA Joint Regulatory Conference. Themed “CGMP: Quality Through Science and Innovation,” this year’s event will delve into the pivotal role effective quality systems play in ensuring an ongoing state of control throughout the product lifecycle. As a Silver Sponsor at this year’s event, Lachman […]
This morning, the FDA published the OTC Monograph request Fee rates for FY 2024 in a pre-publication Federal Register notice (here); these rates cover fees for OTC monograph order requests (OMORs) for which there are Tier 1 and Tier 2 requests. The distinction for the two classifications of OMORs are a Tier 1 request (usually […]
We had predicted, based on mid-month statistics (here), that August would be a big month for approval actions and, boy, was it! The OGD issued ninety-six full-approval actions along with twelve tentative-approval actions for a total of 108 approval actions. This was the second biggest month in FY 2023, behind the 117 approval actions in March […]
Over the Labor Day weekend, the FDA provided the latest full statistical report for the Office of Generic Drugs (here). The news continues to be good on the approvals front as the OGD issued sixty-nine full approval actions (one more than we captured in our unofficial peek (here) as the OGD snuck one by us). […]
