Well, in the dietary supplement battle for the erectile dysfunction (ED) market, it seems that FDA continues to find supplements that contain undeclared drugs. In a public notification today, FDA advised consumers not to use yet another product for ED (see here). As reported previously, it seems that FDA issues a few notices a month […]
The answer to the question of whether current cleaning validation limits generally in use in the industry (1/1000th of the minimum therapeutic dose of a drug product or 10 ppm) should be revised in favor of a Health Based Exposure Limit (HBEL) based limit was one of the major discussions at a “Workshop on the […]
The first Activities Report of the Generic Drug Program FY 2018 (here) issued today and it is a record breaker for approvals and Complete Response Letters (CRL). FDA broke the 100 mark with 101 approval actions with 87 full approvals (AP) and 14 tentative approvals (TA) (we predicted about 84 APs and 13 TAs back […]
We are pleased to announce that Jose L. Toro has accepted the position of Principal Consultant in the Compliance Practice at Lachman Consultants, effective November 13, 2017. Dr. Toro has extensive R&D Quality, and Quality Operations experience in the pharmaceutical industry. He specializes in the transformation of Quality and Technical Services organizations including Quality Systems, […]
The Path to Bioequivalence – Great Progress – Great Opportunities, was presented by Charlie DiLiberti, President, Montclair Bioequivalence Services LLC, at this week’s Association for Accessible Medicines (AAM) meeting. Charlie pointed out the great progress FDA has made in developing new bioequivalence techniques or alternate methods through the GDUFA regulatory science initiative. He pointed to […]
I was lucky enough to moderate the panel on the Priority and Expedited Review with panel members Scott Tomsky and Kurt Karst at the Association for Accessible Medicines (AAM) on November 8, 2017. You all know them and it was interesting that the three of us were, without a doubt, on the same page. What […]
Lots of topics have been discussed on the first two days of the Association for Accessible Medicines (AAM) Fall Technical Conference. Many of the detailed presentation and speakers’ comments had what I refer to as hidden gems that might have escaped full view. Here are some of the noteworthy tidbits: What about those ANDAs that […]
If you have been reading my blog regularly, I guess I have gotten much of the reading of the wind correct because there was not a lot of new information in Cook’s (Kathleen Uhl M.D., Director, Office of Generic Drugs) talk at this year’s Association of Accessible Medicines (AAM) Fall Technical Conference in Bethesda, MD. […]
The FDA today posted a revised draft guidance (here) on the Pre-submission Facility Correspondence (PFC) required to gain a priority review under GDUFA II. We previously reported on the initial draft guidance here and did not think it could get worse — but apparently we were wrong. Many in the industry have complained that with […]
While we are currently waiting for the official statistics for the approval actions for the first month of GDUFA II, a review of the FDA All Approvals List (here) for that month gives us encouragement. It appears that OGD has approved about 84 ANDAS and tentatively approved 13 ANDAs. These numbers may go up a […]
