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The FDA may refine its planned quality metrics program to include rankings of individual drugmaker quality — at the request of industry — that will show how a company’s quality system stacks up against its peers. Read More
Drugmakers should evaluate a product’s UV-visible absorption spectrum before starting clinical development, the ICH says in a new guideline that will standardize photosafety testing standards across the EU, Japan and U.S. Read More
The drug industry wants the FDA to drop plans to require drugmakers to report manufacturing stoppages that will result in shortages within five days of the stoppage occurring. If any timeline is imposed, 15 days is adequate, industry says. Read More
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
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The Canadian government has released a draft guidance aimed at streamlining the approval process for basic clinical trials using positron-emitting radiopharmaceuticals, or PERs.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