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The FDA has laid out the procedures drugmakers should follow in preparing for critical path innovation meetings designed to bring drugmakers, patient groups and regulators together to decide how to use experimental and untested methodologies that can advance drug development. Read More
FDA Office of Generic Drugs Director Kathleen “Cook” Uhl is stepping down for several months to undergo treatment for colorectal cancer. She will be replaced in the interim by John Peters, head of OGD’s Office of Bioequivalence. Read More
The U.S. Supreme Court has rejected another generics liability petition, this one from PLIVA seeking to appeal an Iowa Supreme Court ruling finding the drugmaker open to failure-to-warn claims. Read More
UK inspectors cited 19 companies for critical pharmacovigilance weaknesses in the fiscal year ending March 31, 2014, roughly even with the 18 citations in the previous year. Read More
Making good on its promise to encourage use of new and better technologies in drug manufacturing, the FDA has issued its first guidance for drugmakers using near infrared technology to measure product quality. Read More
The European Medicines Agency has released its recommendations for the 2015/2016 seasonal influenza vaccine composition, setting the clock for when manufacturers have to submit their strain variation applications to June 15. Read More
European regulators are updating the product information for Novartis’ osteoporosis and bone loss treatment Aclasta to include stronger warnings about the risk of severe jaw disease and are introducing a patient reminder card to minimize the risk. Read More
Drugmakers sparred with consumer and patient advocates at a Friday public hearing on the FDA’s proposed rule to give generics makers the ability to update label safety information independently — with generics firms opposing the rule and advocacy groups supporting it. Read More
For the first time, the European Medicines Agency has produced a guideline on clinical trial design for drugmakers developing targeted products to treat lupus — an effort by the EMA to encourage more companies to target the underserved disease. Read More
Drugmakers are being asked to partner with the NIH, academics and biotechnology companies to develop new antibiotics, under a White House plan announced late Friday. Read More