What’s New in Regulatory Science

Clinical Investigator (Sponsor)

CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.

The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development

Certain Broselow Pediatric Emergency Rainbow Tapes were manufactured with incorrect information on the tape.

Webpage providing notices of updates to FDA’s STIC webpages for antibacterial and antifungal drugs.

KRASNIY OKTYABR INC. USA. of BROOKLYN, NY, is recalling its “ARAL SILVER VOBLA” brand “ARAL”, because the product was found to be uneviscerated.