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UK Self-Regulatory Association Blows Whistle on Four Drugmakers UK Self-Regulatory Association Blows Whistle on Four Drugmakers | 2017-09-20 | FDANews Simplifying Global Compliance Home » UK Self-Regulatory Association Blows Whistle on Four Drugmakers Pharmaceuticals / Regulatory Affairs A UK drug-industry trade association flagged Astellas, Norartis, Pfizer and Tor Generics for violating the group’s good-conduct guidelines. The Prescription Medicines Code of Practice Authority, a self-regulatory arm of the Association ... Read More
TGA Announces Tougher Rules on Unfinished GMP Applications Australia’s Therapeutic Goods Administration said it will crack down harder on incomplete GMP clearance applications. The move comes in the wake of a sharp increase in requests for clearance to produce drugs overseas, which have increased 140 percent since 2010. About 60 percent of the applications lack sufficient evidence that production facilities are in compliance with ... Read More
Opioid Commission Seeks to Delay Its Reporting Deadline New Jersey Gov. Chris Christie requested a one-month extension of the Oct. 1 deadline for delivery of the final report by the national opioid-crisis commission, which he chairs. In his letter to President Trump requesting the delay, Christie says the commission plans to meet with Veterans Administration officials and drug industry representatives this month and to ... Read More
Gilead Petitions for Rehearing of Overturned FCA Verdict Gilead Sciences petitioned the Ninth Circuit Court to reconsider its decision allowing a False Claims Act case against the company to proceed. In July, the court reversed a dismissal of the case. Gilead’s petition argued the ruling conflicts with the materiality test established in Universal Health Services Inc. v. United States. In that decision, the U.S. ... Read More
The Case for Intelligent Design (and Infrastructure) in Life Science Biologics R&D New White Paper from IDC Health Insights examines industry trends, new challenges and emerging capabilities in biologics. With many recent blockbuster patents expiring, the pharmaceutical industry finds itself in the middle of a transformation. Leading life science organizations are updating their business strategies to include the ３次元 お尻の丸みと下着の食い込み具合のバランスが最高なエロ画像まとめ 38枚 pursuit of a new market opportunity – the ... Read More