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The FDA replaced its 14-year-old draft guidance on cGMPs for the production of medical gases, relaxing some recommendations on expiration dating and warehousing procedures.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