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.
Three years after placing heavy restrictions on GlaxoSmithKline’s type 2 diabetes drug Avandia, the FDA said Nov. 25 it is relaxing those restrictions in line with its advisers’ recommendations. Read More
Drugmakers that face multiple disputes with doctors over payments reported to the Centers for Medicaid & Medicare Services (CMS) under the Physician Payment Sunshine Act will likely face an audit by the agency. Read More
The European Medicines Agency on Tuesday launched a collaborative five-year program aimed at developing a pan-European framework for monitoring vaccines throughout their lifecycle. Read More
The FDA is seeking input on the effectiveness of risk evaluation and mitigation strategy (REMS) programs as it weighs whether new methods of communicating drug risks in REMS are needed. Read More
The FDA is investigating reports that emergency contraceptives such as Teva’s Plan B One-Step lose effectiveness in women over 165 lbs. and don’t work at all for women over 175 lbs. Based on its review, labeling changes for the drugs may be forthcoming. Read More
The EMA has put Boehringer Ingelheim's hepatitis C drug candidate faldaprevir on a speedy review pathway based on studies involving 3,300 patients. Read More
Three years after placing heavy restrictions on GlaxoSmithKline’s type 2 diabetes drug Avandia, the FDA said Monday it is relaxing those restrictions in line with its advisers’ recommendations. Read More
Drugmakers have 14 additional calendar days to comment on recently revised GDUFA question-and-answer guidance after technical difficulties prevented stakeholders from submitting comments on Regulations.gov. Read More
While advances in technology have improved the purity profile of urokinase-based drugs, EU regulators are urging makers of these drugs to estimate the risk that an individual dose of a product might be contaminated with pathogens. Read More
Amgen is the latest drugmaker caught up in the FDA’s recent flurry of enforcement letters for false or misleading promotional materials. An ad developed by the company for its anemia drug Aranesp omitted risks and inflated efficacy claims, the agency says. Read More
Finalized guidance on preclinical considerations for gene and cellular therapies, posted Monday, reiterates the agency’s position that sponsors should focus on five objectives in preclinical trials. Read More