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 […]
The FDA has issued a white paper on “CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development.” The paper details a program the center intends to establish whereby the goal is to promote QMM throughout the industry. Lachman recently issued a blog relating to this initiative that can be found here. […]
Join us September 28th, 2023, at 10:00 AM EDT for A Lachman Learning Experience. Where are you on your Annex 1 journey? Have you created a measurable plan for progress? Assess your current position and start making plans for the future by attending this highly informative and valuable webinar. Join Lachman Consultants’ Executive Director Keith […]
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 […]
Have you ever had a tough time understanding some of the more complex guidance documents that the FDA issues that fall outside our specific areas of expertise? Yes, if we are being completely honest, it has probably happened to us all at one time or another. Fortunately, it’s about to get easier thanks to an […]
