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FDA publishes an International Council for Harmonization draft guidance on good clinical practices intended to improve clinical trials.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