With six (6) reporting days left in the month, the FDA’s All Approvals List (here) has identified 43 full ANDA approval actions and 10 tentative approval actions. While this represents a bit slower pace for approval actions, there is still time to meet FY 2020 monthly averages by the end of the month. We want […]
In any analytical laboratory that performs cGMP testing, data review is required. However, to an analytical chemist that prefers benchwork, reviewing the data of a fellow analyst is often deemed an undesirable chore. The data reviewer rarely gets a “Thank you” for pointing out irregularities in documentation. The role of the data reviewer is to […]
With ANDA approval, one would expect that market entry would soon follow application approval, right? Wrong! The data suggests that only about 40% of generic drugs approved in any year are actually launched in that year and, after 5 years, there are still about 30% of those products that have still not launched. While this […]
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Today, the FDA finalized an older draft guidance from August 2017 on repackaging of solid oral dosage form product from original containers into unit dose packaging that provides firms the ability to do so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 […]
