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Celator Pharmaceuticals has received a drug enforcement promotion letter as a result of a drug it showcased during the annual meeting of the American Society of Clinical Oncology (ASCO). Read More
The FDA intends to clarify its expectations for demonstrating the interchangeability of biosimilars with reference products, an FDA official said. Read More
When planning an international clinical trial, setting endpoints that are clinically meaningful across regions and planning ahead for local factors are recommended in draft FDA guidance. Read More
Lima & Pergher Industria failed to provide stability data to ensure its drug products’ expiration dates and did not perform microbiological testing on each finished product, the FDA said in a warning letter to the Brazilian company. Read More
The cancer moonshot’s blue ribbon panel made 10 recommendations to the National Cancer Advisory Board to guide scientific direction for the national research initiative, specifically organizing an immunotherapy clinical trials network. Read More
An FDA inspection found microbiological contamination of drugs purporting to be sterile at a Bausch & Lomb manufacturing facility in Florida, according to a Form 483 handed to the company. Read More