FDA releases the FDA-483 with two observations from a September inspection at the Sun Pharmaceutical facility in Punjab, India.
FDA releases the FDA-483 with three observations from an inspection at Indias Stride Pharma Science.
FDA grants HighTide Therapeutics a fast track designation for its investigational new drug, HTD1801, for treating patients with primary sclerosing cho...
CDRH chief medical officer William Maisel reaffirms the agencys intention to modernize its Quality System regulation for medical devices by harmonizin...
FDA approves an Obalon Therapeutics PMA supplement for the Obalon Touch Inflation System for use in inflating the Obalon Balloon, a swallowable gas-fi...
Federal Register notice: FDA announces an 11/2 joint advisory committee meeting to review a Sage Therapeutics NDA for its proposed postpartum depressi...
Federal Register notice: FDA makes available a draft guidance entitled Good Review Management Principles and Practices for New Drug Applications and B...
Federal Register notice: FDA makes available a final guidance entitled ANDA Submissions Content and Format.