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The European Commission formally adopted updated regulations on good manufacturing practices for pharmaceuticals generally and for investigational drugs and clinical trials more specifically. Read More
In a significant policy shift, China plans to accept data from foreign clinical trials in its drug approval process if the drug is already approved overseas. Read More
The European Medicines Agency added answers to 60 new questions in its list of inquiries from stakeholders regarding the launch of its new EudraVigilance drug safety reporting program. Read More
The European Medicines Agency published a question-and-answer document for assessors of periodic safety update reports, or PSURs, as a part of good pharmacovigilance practices. Read More
Medicare Part D beneficiaries could shop for drugs at more pharmacies and take advantage of cheaper new generics sooner under revised rules proposed by the Centers for Medicare and Medicaid Services. Read More
The FDA unveiled its new regenerative medicine oversight framework — the regulation of promising stem cell treatments, engineered tissues and cell therapies — by publishing four guidance documents focused on speeding development and clarifying the agency’s enforcement actions over the next three years. Read More