We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Consumer group Public Citizen is calling on the FDA to send warning letters to four drugmakers to withdraw ads for five Type 2 diabetes drugs promoting off-label uses for weight loss or blood pressure reduction. Read More
European regulators singled out timely access to novel drugs and assuring product, supply chain and data integrity as some of the main goals in a newly released draft common strategy to 2020. Read More
Otsuka is suing to block the FDA from allowing generic versions of its blockbuster antipsychotic Abilify years before the drug’s orphan product exclusivity runs out. Read More
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
Drugmakers planning to assign clinical trial participants to a separate arm of the study based on baseline monitoring must report those plans to the European Medicines Agency, including which factors — called covariates — they plan to rely on to make those assignments. 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