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It is arranged in seven sections, with provisions in each arranged chronologically. If the date is listed as "upon enactment," it means no date was specified in the statute; however, in many cases, regulatory agencies may need to issue guidance or regulations before the provision can be implemented. The information is based on the two health care reform bills: H.R. 3590, which contains the bulk of the reform language, passed the Senate in December, passed the House March 21, and was signed into law March 23; and subsequent fixes in the budget reconciliation bill, H.R. 4872, which cleared the House March 21 and Senate March 25, and the president was expected to sign March 30. The chart also borrows from a comparison chart of pharma provisionsin the two bills by Ian Spatz of Manatt, Phelps & Phillips.
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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.’
In this second of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet which animal testing models have alternative options and highlights where further investment and research is needed to develop appropriate alternatives.
A “basket approach” to phasing out animal testing could help identify areas where “moonshot” research is required to implement new approach methodologies, according to EU industry federation EFPIA.
Vertex said it reached “a broad reimbursement agreement” with the National Health Service for its once-daily, triple combination treatment for cystic fibrosis. As for reimbursement in the rest of Europe, the company is targeting Ireland, Denmark and Germany next.