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The settlement, the largest of its kind, also resolves claims that the company did not meet obligations to report suspicious orders of controlled substances. 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
Congress is looking into making statutory changes to the way FDA governs off-label use of medical products and other pre- and postmarket communications between medical manufacturers, physicians and patients. Read More
The Australian Therapeutic Goods Administration issued an industry guidance proposing to quickly approve certain types of low-risk variations to registered medicines without requiring evaluation, allowing sponsors to implement the changes immediately. Read More
The White House could be pushing for lower prices by way of speeding drugs to market and promoting competition—even internationally—according to a draft executive order that could have the president’s signature soon Read More
The FDA has released a new draft guidance that clarifies the Part 11 regulations for electronic records and signatures as they apply to clinical trials, including validation of mobile and wearable technology and the use of outsourcing and contracting. Read More
The FDA has broadened its import ban against Indian manufacturer Ipca Laboratories to include four drugs previously exempted due to shortage. Only Ipca’s anti-malarial API remains exempted and can be imported into the U.S. Read More
The European Medicines Agency recommended eight new drugs for approval, including two combination treatments for hepatitis C, two therapies for advanced cancers and one drug for relapsing multiple sclerosis. Read More