Mass-spectrometry analysis shows sildenafil (Pfizer's Viagra) contamination in samples of "100% Natural" erectile dysfunction supplement Niagra Actra-Rx and Actra-Rx from Body Basics, Alberto Sabucedo, PhD, chemist for the International Forensic Research Institute, et al. report in a research letter published in JAMA Feb. 4. Products contained an average of 55 mg per pill, authors say. Niagra is not the first sexual function supplement product found to contain sildenafil (1"The Tan Sheet" June 30, 2003, In Brief and 2"The Tan Sheet" April 14, 2003, p. 6)...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.
Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.