FDA warns American Contract Systems about Quality System violations in its work as a medical device manufacturer and contract sterilizer.
A new FDA drug safety alert warns that when Novartis multiple sclerosis drug Gilenya (fingolimod) is stopped, the disease can become much worse than b...
Sen. Bernie Sanders and Rep. Ro Khanna say the will introduce legislation aimed at forcing drug companies to reduce the price for branded prescription...
FDA approves an Elite Pharmaceuticals ANDA for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets).
Federal Register notice: FDA submits to OMB a new information collection entitled Survey of Current Manufacturing Practices for the Cosmetics Industry...
Federal Register notice: FDA seeks comments on a proposed framework for regulating software applications disseminated by or on behalf of drug sponsors...
FDA releases its latest batch of Warning Letters that include American Contract Systems, Product Packaging and Surmasis Pharmaceutical.
FDA commissioner Scott Gottlieb and CDRH director Jeffrey Shuren discuss steps being taken to ensure that FDA is consistently the first regulatory age...