A federal court ruling blocks FDA from enforcing the pharmaceutical pedigree requirements set forth in the Prescription Drug Marketing Act. The bench ruling was issued Dec. 4 by Judge Joanna Seybert of the U.S. District Court for the Eastern District of New York. Secondary distributors RxUSA Wholesale, Alden Surgical, Atlantic Biologics, Bell Medical Services, Truxton, Hygen Pharmaceuticals and Stat Pharmaceuticals filed for the preliminary injunction Sept. 20, seeking to prevent FDA from implementing the final pedigree rule. Magistrate Judge Kathleen Tomlinson recommended Nov. 30 that the district court grant the preliminary injunction, saying that plaintiffs have demonstrated the provision of the PDMA exempting authorized distributors from pedigree requirements may be ruled unconstitutional. FDA announced this summer that it would allow to expire a more than 10-year long stay that has delayed implementation of the PDMA pedigree requirements (1"The Pink Sheet" July, 10, 2006, p. 15)...
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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 government has explained how to navigate the UK’s regulatory and market access funding mechanisms.
The Council of the EU’s vision for the pharma reform package includes a stronger role for member states regarding the supply of medicines and the prevention of indication-stacking for orphan drugs.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
