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Federal Register notice: FDA determines that Norflex (orphenadrine citrate) injection and extended-release tablets were not withdr...[ Price : $8.95]
FDA releases the form FDA-483 with 10 observations from an inspection at the Telangana, India-based Aurobindo Pharma Unit IX activ...[ Price : $8.95]
The FDA Digital Health Center of Excellence publishes a 2022 report on non-device software functions.[ Price : $8.95]
FDA publishes a draft guidance to further explain but not change the Voluntary Malfunction Summary Program.[ Price : $8.95]
FDA releases the form FDA-483 with 16 observations from an inspection at the Pradesh, India-based Lupin Unit 1 drug manufacturing ...[ Price : $8.95]
FDA publishes a proposed rule to make the investigational new drug annual reports more comprehensive and similar to those in other...[ Price : $8.95]
FDA publishes a draft guidance on the content of human factor and usability engineering information to be included in medical devi...[ Price : $8.95]
Two stakeholder associations comment on an FDA draft guidance on general clinical pharmacology considerations for pediatric studie...