FDA releases the FDA-483 with 10 observations from an inspection at Indias Shilpa Medicare Limited.
FDA issues a guidance on fulfilling new labeling requirements for susceptibility test interpretive criteria for prescription systemic antibacterial an...
Federal Register notice: FDA sends to OMB an information collection extension request for Data To Support Drug Product Communications as Used by FDA: ...
The American Hospital Association urges FDA to take steps to reduce the regulatory burden on hospitals involving compounded drugs and medical device c...
Four drug stakeholders ask FDA to revise its draft guidance on REMS format and content.
Federal Register notice: FDA makes available a draft guidance entitled Refuse to File: NDA and BLA Submissions to CDER.
Tremeau Pharmaceuticals says it has recently reached agreement with FDA on the development requirements to support an NDA for TRM-201 (rofecoxib), whi...
Federal Register notice: FDA establishes a Susceptibility Test Interpretive Criteria Web site that is intended to help efficiently update such criteri...