Bowman Cox
Executive Editor
Latest From Bowman Cox
US FDA, USP Raise Questions About Valisure’s Assertions Of Benzoyl Peroxide’s Benzene Risks
The US drug regulatory authority and standard-setting organization are evaluating the drug-screening venture’s findings regarding stability and potential carcinogenic risks associated with the widely used acne treatment, which includes Rx formulations.
US FDA Seeks More Power To Confront ‘Shadow’ Factory Challenges
Agency wants more information about API suppliers as it winds up case against KV Tech for hidden use of Dr. Reddy’s plant and seeks to find manufacturer of contaminated eye drops that disappeared.
US FDA Pharmaceutical Quality Operations Chief Outlines Paths To Quicker Inspections
As US pharmaceutical inspectorate advances toward pre-pandemic inspection cadence, there's new focus on accelerating site inspection process, as well as effort to improve retention with quicker, more targeted training. OPQO chief Alonza Cruse reviews key ideas at GMP conference.
US FDA, USP Raise Questions About Valisure’s Assertions Of Benzoyl Peroxide’s Benzene Risks
The US drug regulatory authority and standard-setting organization are evaluating the drug-screening venture’s findings regarding stability and potential carcinogenic risks associated with the widely used acne treatment, which includes Rx formulations.
US FDA's Cruse Outlines Paths To Quicker Inspections
As US pharmaceutical inspectorate advances toward its pre-pandemic inspection cadence, there is a new focus on accelerating the site inspection process, as well as an effort to improve retention with quicker, more targeted training. OPQO chief Alonza Cruse reviews key ideas at GMP conference.
Drug Makers Look To Simplify Application Process With New ICH Guidance On Platform Methods
As ICH member countries prepare to implement Q2(R1)/Q14 guidelines, industry is focusing on provisions in both for platform analytical procedures, which applicants for drug approvals and biologics licenses could use to reduce method validation requirements. Pfizer undertook the first commercial application of the platform analytical approach, which is widely used in development.