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The Reagan-Udall Foundation unveiled an online directory of dozens of pharmaceutical company policies on expanded access to investigational therapies. Read More
The FDA issued a revised version of its ICH-developed guidance on completing the clinical overview section of the Common Technical Document, including more details on risk-benefit submissions. Read More
The FDA does not intend to object to an institutional review board waiving informed consent requirements for certain clinical investigations considered to be “minimal risk,” according to a new agency guidance effective immediately. Read More
The agency plans to use the pilot to assess industry’s ability to meet the DSCSA’s requirements, including identifying illegitimate products and preventing diversion. Read More
A recent survey revealed that drugmakers are facing some challenges in using the European Medicines Agency’s PRIME program for priority medicines, which recently marked its one-year anniversary. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended 11 products for new marketing authorizations this month, including five orphan drugs. Read More
The court made the ruling in response to a challenge by Actavis Pharma, Endo Pharmaceuticals, Janssen Pharmaceuticals, Purdue Pharma and Teva Pharmaceuticals. Read More
Following Hospira’s recall last month of sterile sodium bicarbonate injections, the FDA has extended the expiration dates for more than 90 lots to help alleviate a critical shortage of injectable drugs. Read More
PhRMA and AdvaMed expressed “grave concerns” about the FDA’s final rule clarifying when tobacco products are regulated as medical products, saying that the rule’s altered “intended use” definition is overbroad in its restriction of communications. Read More