The Report issued each year by the Office of Compliance (OC) is a treasure trove of facts and figures espousing the accomplishments of the OC. The 32 page document (which can be found here) provides a detailed account of OC actions in the enforcement arena, guidance area, consumer awareness and education area, actions relative to […]
Today, in the Federal Register (here), the FDA announced a portion of its continuing modernization plan relative to better assessing its summary of approval that FDA prepares for all new NDA and BLA approvals. The notice asked for public comment on “the Clinical Data Summary Report Pilot program as part of the Agency’s continuous assessment […]
From the news stories on the price fixing suits, to the reported revelations about quality in the generic drug industry, or to the publication of a book titled “Bottle of Lies”, it has not been a good start to the news cycle for the generic drug industry this week. The report on price fixing was […]
In my own humble opinion, Scott Gottlieb’s resignation will come as a blow to both the industry and the public health of our nation. Dr. Gottlieb will stay in his position for about a month. There is no speculation as to whom his replacement will be, and, while some of the news outlets cite his […]
