FDA publishes a question-and-answer guidance on the transition provision of the Biologics Price Competition and Innovation Act under which application...
Federal Register notice: FDA seeks comments on an information collection extension for medicated feed GMPs.
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Kyowa Hakko Kirins Fasenra (benralizumab).
Federal Register notice: FDA makes available a draft guidance entitled Soft (Hydrophilic) Daily Wear Contact Lenses Performance Criteria for Safety a...
Online pharmacy and testing laboratory Valisure says it has detected NDMA contamination in some lots of metformin from several companies.
Researchers say the median cost for developing a new drug between 2009 and 2018 was $985 million.
The U.S. government files a False Claims Act suit against Mallinckrodt ARD (previously Questcor Pharmaceuticals) for allegedly underpaying Medicaid re...
FDA orders a Boxed Warning to be added to labeling for Mercks Singulair and its generic forms on the risk of neuropsychiatric events.