A Department of Justice press release (here) announced a 19 count indictment against 9 individuals “with conspiracy to commit mail and wire fraud, mail fraud, wire fraud, aggravated identity theft, conspiracy to defraud the United States, and failure to maintain adequate records.” Basically, the press release goes on to describe fraudulent activities relative to the […]
The Inactive Ingredient Database (IID) has been around for a long time, but it was not very user friendly, was not updated frequently, and failed to provide something we call the maximum daily exposure (MDE) for each inactive ingredient in each route of administration. Well, FDA has been working on the list of inactive ingredients […]
As part of the Agency’s ongoing efforts to ensure patient’s access to drugs, FDA is continuing to develop and evaluate a list of bulk drug substances that 503B Outsourcing Facilities can use in compounding, when it has been determined that there is a clinical/medical need that can’t be met by an available FDA-approved drug. On […]
The FDA announced the FY 2021 biosimilar user fees this morning on its Federal Register pre-publication page (here). The new fees can be found in the table below. BSUFA FY 2021 User fees Fee Category Rates for FY 2021 Rates for FY 2020 Percent Change Initial BPD $102,494 $117,987 -13.2% Annual BPD $102,494 $117,987 -13.2% […]
Today, the FDA finalized an older draft guidance from August 2017 on repackaging of solid oral dosage form product from original containers into unit dose packaging that provides firms the ability to do so without (in most cases) performing additional stability studies. The Agency notes that it “received a few comments on the revised draft […]
On Tuesday, July 21, Mary Oates, Ph.D., Vice President, Compliance Services, will be participating in a webinar organized by Informa, publishers of the Pink Sheet and Scrip. Mary will be a panelist in a session on Virtual Drug Inspections, occurring at 2 PM EST. The entire webinar series, which is taking place over a 24 […]
Two prepublication Federal Register (FR) notices provide the backdrop for the historical demise of several products, and, with the final decision being affirmed that the products lack substantial evidence of effectiveness, they may no longer be marketed unless a New Drug Application with clinical data supporting the indications is submitted and approved. Vasodilan injection and […]
Well, there were some hidden tentative approval actions that must have been posted fairly late after June was over as the OGD official numbers released for June show OGD had 14 Tentative Approval (TA) actions (we reported just 5 in our post on July 6 [here]). (However, when looking at the FDA all approvals list […]
While the Lachman Blog usually focuses on issues in drugs, devices, and biologics (the areas we consult in), we are swimmingly happy to take a walk (or dive) on the wild side to address a fishy problem that caught our attention. The FDA noted in a Federal Register Notice today (here) that contained this particular […]
One unexpected outcome of the current global pandemic is that the world has received a crash course in basic microbiology. Ask just about anyone, anywhere in the world today, and they can tell you that diseases such as Covid 19 are caused by an organism too small to see, that can be passed person to […]
