Since the implementation of the CARES Act reporting requirement, the question continues to be asked: Is it really a requirement? The answer is yes, and now it is no longer recommended, but is stated as “should” in the newly published Final version of the Guidance for Industry (GFI) “Reporting Amount of Listed Drugs and Biological […]
A presentation delivered by Office of Generic Drugs Director, Iilun Murphy, M.D. during the members-only Regulatory and Policy meeting at the start of AAM’s annual meeting provided seven tips for ANDA sponsors with regard to their ANDA submissions: Submit a clear cover letter. Describe what is being submitted. State whether the submission includes a labeling […]
While most of you are aware of these facts published by FDA last week, I found this article quite interesting, and it may teach us a thing or two! And because many of our readers come from different backgrounds than us in regulatory, the FDA, or the healthcare industry, it may provide some prospective on […]
The 101-page Federal Register (FR) document published on the prepublication page of the FR today (here) describes the rule in detail and provides responses to comments received by stakeholders on the proposed final rule. The FDA states: “We are amending part 820, primarily to incorporate by reference ISO 13485, Medical Devices—Quality Management System Requirements for Regulatory Purposes. […]
Today, the FDA is warning consumers of potentially contaminated copycat eye drops that are unapproved new drugs that “copy the Bausch + Lomb’s Lumify brand eye drops, an over-the-counter product approved for redness relief.” While the FDA notes that it has not received any specific reports of adverse events with the three products named below, […]
As a proud Silver Sponsor of this important conference, we’ll be looking for you at Access! 2024. This annual meeting of the Association for Accessible Medicines (AAM) is happening in Tampa, Florida at the JW Marriott from Monday, February 5th through Wednesday, February 7th, 2024. Visit with us at Booth #11. The Lachman Consultants team […]
This morning, when I read a Decision and Order issued by the United States Court of Federal Claims regarding a motion that was granted in part, denied in part, and filed on behalf of a pharmaceutical company and the FDA, the hair on the back of my neck stood on end. Now, I must state […]
Marty Shimer, Executive Director at Lachman Consultants, wrote a great post (here) about ANDA suitability petitions and the new GDUFA goal dates being assigned to them. His post gives us hope that the new system in place will provide some meaningful timelines for actions on ANDA suitability petitions used to make certain permissible changes from […]
Well, after a somewhat underwhelming start to FY 2024 (which began in October 2023), as reported here, it looks like things are picking up on the approval front for ANDAs. With approval postings through January 17th available today, the OGD has issued thirty-two full-approval actions and ten tentative-approval actions. This should bode well for a better January […]
Yesterday, the Office of Generic Drugs published the November addition to its FY 2024 Generic Drugs Program Monthly and Quarterly Activities Report (here). Officially, the OGD issued 51 final ANDA approval actions and 17 tentative-approval actions for a total of 68 approval actions. Of the 51 final approval actions, four were for first-time generics and six […]
