Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of ...

Two former US Food and Drug Administration (FDA) officials have commented on and proposed changes to the agency’s recent ...

Pharmaceutical regulatory consulting for drug developers and CROs: IND CMC, method validation, NDA strategy, and FDA ...

Add Yahoo as a preferred source to see more of our stories on Google. The FDA's new draft guidance clarifies how companies can gain regulatory validation for their alternative preclinical model.

Draft recommendations allow skipping at least one U.S.-reference comparative PK study when analytical and other evidence supports biosimilarity, including use of ex-U.S. comparator data in defined ...

The FDA has released a draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices, according to an FDA news release. The guidance is meant to ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...