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The European Medicines Agency (EMA) says it is no longer acceptable for sponsors to conduct placebo-controlled clinical trials when developing monotherapy drugs for lipid disorders. Read More
The FDA’s proposal to establish tighter controls on hydrocodone combination drug products such as Vicodin should only apply to doses 5 mg or higher, drugmakers say. Read More
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
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