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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of method development and specification-setting exercises to show how quickly the drug dissolves, the FDA says in draft guidance released July 31.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
Vaccines makers should submit individual case safety reports and attachments to the Vaccine Adverse Event Reporting System using either the direct database-to-database method or the eSubmitter tool method, the FDA says. Read More
The primary efficacy endpoint in clinical trials for uncomplicated gonorrhea should be a negative culture at the infection site three to seven days after receiving antibacterial drug therapy, the FDA says. Read More