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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
Swissmedic is revising its drug approval process to streamline authorizations for certain products. The overhaul will take place in several phases, beginning in early 2018. The first revisions will address pediatric drug dosage recommendations. Read More
The European Medicines Agency revised its guideline on first-in-human clinical trials, highlighting the sponsor’s responsibility for mitigating risks to volunteers.in the study design. Read More
The European Medicines Agency revised its guideline on first-in-human clinical trials, highlighting the sponsor’s responsibility for mitigating risks to volunteers.in the 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 adopted five product-specific guidances, effective Jan. 1, 2018, outlining requirements for establishing bioequivalence, including clinical study design. Read More
An FDA advisory committee voted to recommend that Wyeth’s Mylotarg return to the U.S. market as a treatment for CD33-positive acute myeloid leukemia in combination with daunorubicin and cytarabine. Read More
The FDA and the European Medicines Agency released a draft joint plan this month 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 finalized 48 guidances for generics manufacturers, outlining the recommended studies for demonstrating bioequivalence for dozens of active ingredients and combinations, to assist the industry with generating evidence to support ANDA approvals. Read More
The FDA published new product-specific draft guidances for establishing bioequivalence in 20 drugs and combinations. The agency also revised draft guidances for 12 more substances. Read More
An FDA advisory committee voted 12-to-1 against recommending approval of Janssen’s Plivensia (sirukumab) in treating rheumatoid arthritis, saying its safety profile raised too many concerns. Read More