[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Cover Letter Attachments for Controlled Correspondence and ...[ Price : $8.95]
Federal Register notice: FDA withdraws approval of a Vintage Pharmaceuticals ANDA for pemoline tablets after the company requested...[ Price : $8.95]
Federal Register notice: FDA issues a priority review voucher to Krystal Biotech in response to an approved rare pediatric disease...[ Price : $8.95]
FDA publishes an International Council for Harmonization draft guidance on good clinical practices intended to improve clinical tr...[ Price : $8.95]
FDA warns Henderson, NV-based Steiner Biotechnology about multiple violations in its production and labeling of several dental bon...[ Price : $8.95]
FDA accepts for review a GSK supplemental BLA for Jemperli (dostarlimab) in combination with chemotherapy for treating certain adu...[ Price : $8.95]
FDA warns Cypress, CA-based iRhythm Technologies about multiple violations in its production of the ZIO AT cardiac event reporting...[ Price : $8.95]
FDA grants a de novo marketing authorization for Cue Healths Cue Covid-19 Molecular Test, the first at-home Covid test granted a t...