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The FDA cited non-sterile drug manufacturer PrecisionMed for ineffective cleaning to prevent cross-contamination of products at its Tampa, Florida facility. Read More
Population PK analysis is “especially appropriate in children” because it allows the use of sparse sampling, minimizing the total volume of blood sampled, the agency said. Read More
CDER released final guidance on Thursday on submitting next generation nucleotide sequence (NGS) data to support resistance assessments for antiviral drugs. Read More
Amgen’s five-year legal challenge against Sanofi and Regeneron’s competitor for its cholesterol-lowering drug Repatha (evolocumab) is set to continue next month in a Delaware federal court. Read More
The FDA issued a warning letter to Ecometics for serious GMP violations at its Norwalk, Conn., facility, including making drugs on equipment used to make toxic non-drug products. Read More
Testerone level should be used as a surrogate endpoint in phase 3 trials of gonadotropin-releasing hormone (GnRH) analogues for treating advanced prostate cancer, the FDA says in a new draft guidance. Read More