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The European Medicines Agency published its annual report, listing 81 medicines recommended for approval in 2016, including 27 new active substances. Read More
Scheduling conflicts unrelated to the must-pass FDA user fee reauthorization bill postponed a planned markup Wednesday, but the Senate HELP committee has rescheduled the session for today. Read More
Following the FDA’s addition of a Chinese API manufacturer to an import alert early last month, the World Health Organization was left without a prequalified source for the birth control drug levonorgestrel, also known as Plan B. Read More
Australia’s Therapeutic Goods Administration is abandoning its goal of 15-day timelines to process GMP clearance filings from overseas manufacturers. Read More
The U.K.’s Medicines and Healthcare products Regulatory Agency laid out its top 10 priorities for 2017 and 2018 — including developing a model for the agency’s future, post-Brexit. Read More
The EMA is planning to focus on 13 separate initiatives for 2017, ranging from fully implementing its priority medicines review pathway to boosting international cooperation. Read More
The European Medicines Agency Committee for Medicinal Products for Human Use recommended 11 medicines for approval, including four orphan drugs and three biosimilars. Read More
Less than a month shy of mandating electronic submissions of drug and biologic master files in the eCTD format, the FDA has decided to postpone the requirement until May 2018. Read More
The European Medicines Agency says clinical trial master files should also include quality reports and checklists, product certifications and trial-specific computer system guides — essential documents that are not listed as required in ICH Good Clinical Practice guidelines. Read More
India’s top drug regulatory body plans to fast-track approvals for combination products recommended by the World Health Organization to treat HIV and hepatitis B and C. Read More