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New York Senate bill (SB 4909) would require all dietary supplements to contain a statement in their labeling "clearly discernible to a customer" disclosing whether "the product has or has not been tested by [FDA]." The statement would accompany the FDA disclaimer regarding structure/function claims required under the Dietary Supplement Health & Education Act. The bill was introduced in the Senate April 20 and has been referred to the Committee on Consumer Protection
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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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A new pilot aims to take Brazil closer to ‘digital transformation.’
Antibiotics that tackle antimicrobial resistance are to be automatically included in Italy’s Innovative Medicines Fund, which is designed to provide quick access to innovative medicines.
The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.
The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.