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The House Energy and Commerce Committee’s newly released legislative wish-list for overhauling the FDA and incentivizing new drug development includes few generics-friendly proposals, possibly because the generics industry had little input into the 21st Century Cures initiative that developed the proposals. Read More
Nearly half of all serious adverse event reports submitted to the FDA by drugmakers don’t include basic information such as the patient’s age and gender and the event date, a new analysis of adverse event reports shows. Read More
Japanese regulators have notified Novartis Pharma K.K., the Japanese arm of the Swiss drug giant, that they are planning to temporarily suspend the firm from doing business in the country. Read More
The White House in its fiscal 2016 budget proposal Monday asked Congress to appropriate $486 million for CDER, a bump in funding of less than one percent, and $215 million for CBER, an increase of two percent. Read More
The Delhi high court on Friday set aside a government order rejecting Gilead’s patent for hepatitis C treatment Sovaldi, saying the Office of Patents Designs and Trademark had made procedural errors in issuing its decision. Read More
Japanese regulators are weighing whether the agency will need to begin approving some drugs based on Phase II trial data as they implement approval processes for personalized drug products. Read More
Drugmakers should review their inspection standard operating procedures for producing off-site records and allowing FDA investigators to take photos or conduct interviews of employees, following new agency guidance on the topics. Read More
The FDA emphasized flexibility in a final guidance that attempts to harmonize U.S. and International Conference on Harmonisation drug photosafety testing requirements. Read More
The Senate is joining the effort to make the FDA more efficient at approving new drugs, laying out criticisms that the agency is slow and inefficient in a report released yesterday and planning hearings on the issue in the spring. Read More