Medtech supplier Cortland Biomedical said the new designation positions it as a full-service contract manufacturer.

Under Administrative Order 2024-0016, fees for facility registration and CPR are now calculated annually and multiplied by the number of allowable years of validity. For instance, a high-risk food ...

THE Food and Drug Administration (FDA) said Friday that it is set to release a new administrative order that would reduce the timeline of drug registration, especially among imported drugs that have ...

On January 15, 2025, the US Drug Enforcement Administration (DEA) released a proposed rule entitled Special Registrations for ...

Clinical investigations may also meet the FDA definition of “applicable clinical trial,” in which case they must follow the agency’s trial registration and results reporting requirements. There are ...

The FDA has provided supportive feedback in an end of phase 1 type B meeting about the registrational strategy for ELI-002. Based on the feedback from the FDA, the company anticipates submitting a ...