FDA issues Wells Pharma (Houston, TX) a one-item Form FDA-483 after a 6/2021 inspection at the drug outsourcing facility.
FDA releases a final guidance entitled Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the Covid-19 Pandemi...
Federal Register notice: FDA makes available a draft guidance entitled Immunogenicity Information in Human Prescription Therapeutic Protein and Select...
Federal Register notice: FDA makes available a final guidance entitled Population Pharmacokinetics.
Federal Register notice: FDA makes available a revised draft guidance entitled Assessment of Pressor Effects of Drugs.
Federal Register notice: FDA classifies Apples photoplethysmograph analysis software for over-the-counter use into medical device Class 2.
FDA accepts for review a Cytokinetics NDA for omecamtiv mecarbil, an investigational, selective, small molecule cardiac myosin activator for treating ...
In a move to gain Senate backing of his FDA commissioner nomination, Robert Califf promises once in office to crack down on drug companies that gain a...