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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Eli Lilly and PharmaMar were set to make their case before the European Medicines Agency this week as part of re-examination procedures for their respective drugs Kisunla and Aplidin.
Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.
One option for the FDA going forward could be holding an advisory committee meeting on its safety concerns after Sarepta agreed to stop all shipments of its DMD gene therapy.