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The FDA has set a deadline of November 2014 to revise its current good manufacturing practice (cGMP) regulations to strengthen its oversight of pharma supplier quality. Read More
The International Society of Pharmaceutical Engineering (ISPE) is recommending six quality metrics that the FDA should consider collecting from manufacturers as part of the agency’s new quality metrics program. Read More
Janssen’s third try to expand the indication for its anticoagulant Xarelto floundered Thursday when FDA advisors voted to recommend against its approval, citing concerns about the drug’s risks and missing clinical data. Read More
Drugmakers angling for longer patent-term adjustments scored a big win Wednesday as a federal appeals court ruled that the U.S. Patent and Trademark Office (PTO) incorrectly calculated adjustments for three Novartis patents, a ruling that will affect patents across the board. Read More
India has created a formula to calculate the compensation clinical trial subjects will receive in the event of death or serious adverse event, stressing that sponsors must fully inform study subjects about the payments during a videotaped informed consent process. Read More
Drugmakers can now submit adverse event reports to the Therapeutic Goods Administration via email using the international E2B standard alone — a move aimed at reducing manual data entry and duplicate handling of information. Read More
The Canadian government has released a draft guidance aimed at streamlining the approval process for basic clinical trials using positron-emitting radiopharmaceuticals, or PERs. Read More
Health Canada issued guidance last month clarifying how the agency’s several centers will collect and manage information and material submitted by sponsors of prescription drugs. Read More
Doctors and researchers should have full access to clinical trial data on products licensed in the UK to ensure that the cost-benefits, as well as safety and efficacy, are considered in prescribing and coverage decisions, lawmakers say. Read More