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The FDA has added Chagas disease and neurocysticercosis to the list of treatments for tropical diseases eligible for priority review vouchers, bringing the number to 19. Read More
CDER has revised its policies and procedures guide on responding to inquiries about ANDAs, clarifying responsibilities for Office of Generic Drugs and Office of Pharmaceutical Quality staff. Read More
Amgen agreed Tuesday to pay $71 million to 48 states and the District of Columbia to resolve allegations it promoted biologics Aranesp and Enbrel based on misleading claims. Read More
The China State Council is calling for sweeping reforms of the country’s drug regulatory system, including accelerated approvals of novel drugs, specified timelines for deciding applications and increased public access to applications and information. Read More
U.S. Sen. Joe Manchin (D-W.Va.) says he will call for a Senate investigation into the FDA’s decision to allow OxyContin to be prescribed to children as young as 11. Read More
The International Conference on Harmonisation is recommending that drugmakers limit their use of the solvent methylisobutylketone in drug products after two studies showed toxicity in rats and mice. Read More
Manufacturers of highly soluble immediate-release tablets and capsules may use standard release tests instead of method development and specification-setting exercises to show how quickly the drug dissolves, the FDA says in draft guidance released July 31. Read More
AbbVie is launching new attacks on the FDA’s approach to biosimilar labeling, arguing in a letter posted to regulations.gov that the labels have “indefensible” omissions of how biosimilars and brandname biologics differ. Read More
Drugmakers should limit the amount of acetaminophen in pediatric liquid drugs to 160mg/5mL and include a statement highlighting the concentration on the container and labeling to reduce the chance of overdose, the FDA says. Read More
Drugmakers will have to provide more benefit-risk information in common technical documents submitted to the FDA, European Medicines Agency and other regulators, under revised guidance from the International Conference on Harmonisation. Read More