Federal Register proposed order: FDA proposes to exempt certain blood and blood components for transfusion and cell and gene therapy products from ann...
Washington Legal Foundation says the 9th Circuit Court of Appeals should uphold a lower court multi-district litigation decision that federal law pree...
Sidley attorneys say a new FDA final rule expands the ways the agency determines whether a consumer product is intended for drug or medical device use...
The Association for Accessible Medicines recommends broadening an FDA draft guidance on some ANDA bioequivalence studies.
The Pew Charitable Trusts say Congress should give FDA authority to regulate some higher-risk laboratory-developed tests.
FDAs Vaccines and Related Biological Products Advisory Committee votes to recommend the agency authorize the use of Pfizers Covid-19 lower-dose vaccin...
Federal Register notice: FDA sends to OMB an information collection revision entitled Registration of Producers of Drugs and Listing of Drugs in Comme...
Eyenovia receives a complete response letter on its NDA for MydCombi (tropicamide and phenylephrine), indicated for in-office pupil dilation, because ...