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FDA investigators will be able to photograph most areas of a facility during an inspection, including product labels and visible contamination of materials, according to a final guidance issued yesterday. Read More
AbbVie has called off its plans to merge with Ireland-based Shire, citing the U.S. Treasury Department’s recent efforts to dissuade so-called tax inversions. Read More
Indian regulators are establishing a panel of experts to conduct a comprehensive review of existing forms and procedures, and recommend improvements to make the drug application process more user-friendly. Read More
Sponsors of clinical trials for new migraine therapies should focus on enrolling more women of childbearing age early in the drug development process, as more women than men have the condition, according to a new FDA draft guidance. Read More
Dr. Reddy’s Laboratories has settled a class-action lawsuit over its alleged role in delaying generic entry of AstraZeneca’s heartburn drug Nexium in return for assisting plaintiffs in their case against AZ and the remaining generics manufacturer defendants. Read More
A coalition of drugmakers wants to boost performance at clinical trial sites by establishing common standards for good clinical practices and skill requirements for investigators. Read More
India’s national drugs authority is again surveying pharmacists and testing drug samples in an effort to better grasp the extent of the country’s counterfeit and substandard drugs problem. Read More
Pharmaceutical intellectual property rights remain a significant sticking point in a proposed draft of the massive Trans-Pacific Partnership (TPP) trade pact leaked last week. Read More
Two lawmakers wrote to HHS Secretary Sylvia Burwell seeking an analysis of national drug pricing and efforts by the Obama administration to bring rising generic prices under control. The letter is likely a precursor to congressional hearings. Read More