L&S Research receives FDA warning letter for Super Water Pill Caplets, Fusion Multi-Power Tablets, Cyberblast Capsules, Super Fat-Loss Tablets, QuickTrim Complex #1-#4 Caplets, CyberTrim Formulas #1-#4 Tablets, Mega-Fat Burner Tablets, Protabalase (EM and ME formulas) and Palm Springs Elite Total Diet Plan (AM and PM formulas). FDA stated that labeling and promotional materials for the items indicate that they are unapproved new drugs. FDA asked L&S to provide its "intentions for the continued promotion and marketing of these products as OTC weight control drug products"
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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.’
Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.
The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.
The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.
