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 ...

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

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 ...

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 ...

In the final days of the Biden administration, the Drug Enforcement Administration (DEA) released a proposed rule that would allow practitioners ...

The Food and Drug Administration (FDA) has implemented new guidelines adjusting fees while extending the validity of the Certificate of Product Registration (CPR) for health products. Under ...