FDA and HHS announce a final rule that allows FDA-authorized programs to import certain prescription drugs from Canada if specific conditions to ensur...
Novartis Gene Therapies says it will conduct an FDA-recommended pivotal confirmatory study of its AVXS-101 intrathecal formulation in older patients w...
Attorney James Beck says defense attorneys in FDA preemption cases would benefit from reading a recent North Carolina federal court decision that uphe...
Federal Register notice: FDA seeks comments on an information collection extension entitled Use of Public Human Genetic Variant Databases To Support C...
Federal Register proposed rule: FDA proposes to amend its medical product intended use regulations to describe the types of evidence relevant to deter...
FDA denies without comment on potential future action a Taiho petition seeking restrictions on generic versions of its Lonsurf tablets.
FDA says it is ordering labeling changes to benzodiazepines to highlight risks of abuse, misuse, addiction, withdrawal symptoms, etc.
FDA grants priority review for Pfizers Xalkori sNDA to treat some pediatric lymphoma patients.