SUPPLEMENT GMP GUIDELINES FOR "POSITIVE IDENTIFICATION" OF INGREDIENTS may be needed, FDA suggests in an advance notice of proposed rulemaking published in the Feb. 6 Federal Register. In requesting comments on aspects of GMPs that may not have been fully covered in the November 1995 industry-proposed version of supplement GMPs, FDA asks interested parties what might be considered "appropriate testing requirements to provide positive identification of dietary ingredients, particularly plant materials, used in dietary supplements."
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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.’
The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.
The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.
MFN policy would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.
