FDA warns Canadas Apollo Health and Beauty Care about CGMP violations in its work as a contract manufacturer of OTC drugs.
FDA clears a PhotoniCare 510(k) for its TOMi Scope for non-invasive imaging of the middle ear.
FDA clears an Applied BioCode 510(k) for its BioCode Respiratory Pathogen Panel for use on the BioCode MDx-3000 System.
Federal Register notice: FDA announces a 3/4 Vaccines and Related Biological Products Advisory Committee meeting to discuss upcoming flu vaccines.
Federal Register notice: FDA renews for two years the charter for its Patient Engagement Advisory Committee.
Federal Register notice: FDA has renewed for another two years the charter for its Pharmaceutical Science and Clinical Pharmacology Advisory Committee...
FDA sends ViiV Healthcare a complete response letter on its NDA for cabotegravir and rilpivirine, a long-acting regimen for treating HIV-1 infection.
FDA approves a Novo Nordisk NDA for Fiasp (insulin aspart injection) 100 u/mL as a mealtime insulin option for children with diabetes.