The FDA cited a Plattsburgh, N.Y., outsourcing facility after an inspection in February and March found serious deficiencies in the company’s cleanliness and sterility practices. Source: Drug Industry Daily

The Department of Veterans Affairs is linking up with the Institute for Clinical and Economic Review to support use of ICER’s drug assessment reports in coverage and price negotiations with…

The FDA replaced its 14-year-old draft guidance on cGMPs for the production of medical gases, relaxing some recommendations on expiration dating and warehousing procedures. Source: Drug Industry Daily

For the next generation of the FDA’s biosimilar user fee program, the agency is proposing a new model for reviewing 351(k) applications — allowing for additional communication between review teams…

An appropriations bill that would provide $5.2 billion for the FDA in fiscal 2018 got the nod from a House subcommittee Wednesday, bucking the White House’s spending request and giving…

The FDA warned Raritan Pharmaceuticals for violating GMP standards, noting the firm failed to properly test its products, which are meant for vulnerable populations, or to maintain good quality control…

Takeda subsidiary Millennium Pharmaceuticals called on the FDA to withhold approval for generic versions of its drug Velcade (bortezomib) until at least next February, when a relevant exclusivity period expires.…

Texas enacted a law that will allow chronic and terminally ill patients access to stem cell therapies that are unapproved by the FDA. Source: Drug Industry Daily

The FDA surpassed many of its performance goals for generic drug applications through 2016, but the agency needs a plan for the user fees collected but not spent in the…

The FDA implemented a new policy to expedite generic drug reviews in areas of limited competition, and published a list of off-patent branded drugs with no approved alternatives, as the…