FDA commissioner Scott Gottlieb outlines a new regulatory framework he has suggested to Congress for diagnostic tests.
FDA releases the FDA-483 with nine observations from an inspection at Japans Yuki Gosei Kogyo API manufacturer.
FDA publishes a draft guidance and a finalized guidance on voluntary consensus standards for medical devices.
FDA issues an FDA-483 with five inspection observations at Cook Pharmica.
FDA releases an FDA-483 issued following an inspection at Indias Unichem Laboratories drug manufacturing firm.
FDA releases 54 product-specific drug guidances to promote generic competition.
Two Kleinfeld, Kaplan and Becker attorneys analyze major medical device guidance documents issued in the first eight months of 2018.
FDA proposes to amend its rules to require a single electronic format submission for medical device premarket filings, rather than multiple paper and ...