NLEA challenge: Suit claiming the Nutrition Labeling & Education Act violates the First Amendment is pending in D.C. federal court, awaiting a decision from the judge. The suit, filed by Durk Pearson, Sandy Shaw, the American Preventive Medical Association, Citizens for Health and the National Health Federation in California in March 1994, was transferred to the D.C. court over a year ago. The suit claims FDA is violating the plaintiffs' right of free speech by enforcing restrictive health claims provisions ("The Tan Sheet" May 9, 1994, p. 13)...
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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.’
It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.
Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.
Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.
