FDA commissioner Scott Gottlieb says that as part of agency efforts to combat the opioid crisis it has issued a Warning Letter to McKesson for supply ...
FDA Critical Path and Regulatory Science Initiatives director Frank Weichold explains the Centers for Regulatory Science and Innovation program and th...
Allergan applauds an FDA draft guidance with questions and answers on the biosimilar product development process.
Four former FDA CDER and CBER executives join the Parexel regulatory consulting group.
Stakeholders suggest revisions to a draft FDA framework for prescription-drug-use related software.
FDA releases an FDA-483 with six observations from an inspection at Indian drug company Lupin Limited.
A World Health Organization product alert says falsified versions of Takeda/Incytes leukemia drug Iclusig are circulating in Europe and the Americas, ...
FDA appoints CDER Office of Study Integrity and Surveillance deputy director Sally Choe as permanent director of the Office of Generic Drugs.