FDA clears a Visby Medical 510(k) for its point-of-care test for detecting respiratory infections caused by influenza A & B, and Covid-19.
Reps. Finstad and Crenshaw introduce legislation to stop FDA from regulating laboratory-developed tests.
An Indian news service says FDA has sent a Warning Letter to drug manufacturer Granules following a 2024 inspection at the firms facility in Gagillapu...
Ventec Life Systems recalls its VOCSN Multi-Function Ventilators because the devices were serviced using incorrect parts which can lead to device shut...
The Senate Health Education Labor & Pensions committee sets a 3/6 confirmation hearing to review the nomination of Johns Hopkins surgeon and public po...
FDA releases the form FDA-483 with seven observations from an inspection at Chinas Zhejiang Huahai API manufacturing facility.
FDA releases the form FDA-483 with six observations from an inspection at Indias Piramal Pharma API manufacturing facility.
FDA releases the form FDA-483 with seven observations from an inspection at Indias Indoco Remedies manufacturing facility for sterile and non-sterile ...
