NDI Guidance Protects Public Health And Allows Innovation – FDA's Fabricant
Present and former top FDA officials with oversight of dietary supplements defend the draft guidance on new dietary ingredient notifications, saying the document serves important public health priorities and will not be onerous to industry.
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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.’
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The African Medicines Agency is to appoint a director general and become operational at the end of this month.
After almost seven years, China’s NMPA has once again published draft measures for clinical trial data protection, opening these up to public comments. While specific protection periods by drug category are proposed, some clarifications are still needed.
Plan to reorganize the agency into five offices was designed by someone who does not understand the FDA, former long-time agency official Janet Woodcock says. The proposal would eliminate highly specialized expertise in favor of “a big team of generalists,” former Principal Deputy Commissioner Joshua Sharfstein says.