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.’
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
For the Trump Administration, the blockbuster GLP-1 drugs for obesity have become a poster child for the disparity between US and foreign prices.
Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.
