FDA Related News

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 2/04/2022.

Medical Devices

FDA Warning on E25Bio Covid Tests

FDA issues a warning to not use the E25Bio Covid-19 Direct Antigen Rapid Test due to concerns about false results.

FDA Green Lights Domestic Inspections Beginning 2/7

FDA removes its domestic inspection pause and will resume conducting inspections in the U.S beginning 2/7 now that Covid-19 cases are dramatically dec...

Human Drugs

Wells Pharma Hit With 483 After Inspection

FDA issues Wells Pharma (Houston, TX) a one-item Form FDA-483 after a 6/2021 inspection at the drug outsourcing facility.

Human Drugs

Guide on Mitigating Primate Supply Contraints

FDA releases a final guidance entitled Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the Covid-19 Pandemi...

Federal Register

Immunogenicity Drug Labeling Guidance

Federal Register notice: FDA makes available a draft guidance entitled Immunogenicity Information in Human Prescription Therapeutic Protein and Select...

Federal Register

Guide on Population Pharmacokinetics

Federal Register notice: FDA makes available a final guidance entitled Population Pharmacokinetics.

Federal Register

Guide on Drug Pressor Effects

Federal Register notice: FDA makes available a revised draft guidance entitled Assessment of Pressor Effects of Drugs.

Federal Register

Class 2 for Apple Irregular Heart Rhythm Monitor

Federal Register notice: FDA classifies Apples photoplethysmograph analysis software for over-the-counter use into medical device Class 2.

Human Drugs

Cytokinetics NDA for Heart Failure Drug

FDA accepts for review a Cytokinetics NDA for omecamtiv mecarbil, an investigational, selective, small molecule cardiac myosin activator for treating ...