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The FDA failed to follow federal law when it refused to provide exclusive marketing rights to United Therapeutics for its treprostinil formulation, branded as Orenitram, as an orphan drug, the company said in a federal lawsuit. Read More
President Trump said the White House is drawing up documents to officially declare the opioid addiction crisis a national emergency — two days after HHS Secretary Tom Price said the administration would pursue other avenues. Read More
France’s Agency for the Safety of Health Products cited Chinese API manufacturer Chongqing Succeway Pharmaceutical for GMP non-compliance, including one critical finding: active tampering with company data. Read More
The European Commission issued a Statement of Objections to Teva over its 2005 “pay-for-delay” deal with Cephalon in which Teva agreed not to market a cheaper generic for Cephalon’s sleep disorder drug Provigil (modafinil). Read More
Congress is looking into making statutory changes to the way FDA governs off-label use of medical products and other pre- and postmarket communications between medical manufacturers, physicians and patients. Read More
The FDA issued a revised version of its ICH-developed guidance on completing the clinical overview section of the Common Technical Document, including more details on risk-benefit submissions. Read More
The FDA and the European Medicines Agency released a draft joint plan to support the development of pediatric treatments for Gaucher disease — an approach the agencies say can apply to rare diseases in general. Read More
The FDA does not intend to object to an institutional review board waiving informed consent requirements for certain clinical investigations considered to be “minimal risk,” according to a new agency guidance effective immediately. Read More
The European Medicines Agency adopted five product-specific guidances, effective Jan. 1, 2018, outlining requirements for establishing bioequivalence, including clinical study design. Read More
Data integrity, recordkeeping and drug trial oversight violations feature in the UK Medicines and Healthcare products Regulatory Agency’s latest report on good clinical practice inspections. Read More
The European Medicines Agency is provisionally restricting the use of the multiple sclerosis medicine Zinbryta (daclizumab) to patients with highly active relapsing disease that has failed to respond to certain other treatment, and to patients with rapidly evolving relapsing disease who cannot be treated with other medicines. Read More
The European Medicines Agency and the European Network for Health Technology Assessment developed a joint platform for parallel consultations on evidence plans for marketing authorizations and health technology assessments to provide sponsors with simultaneous, coordinated advice on development strategies. Read More