FDA warns Philadelphia, PA-based Medical Products Laboratories about CGMP violations in its manufacturing of unapproved new drugs.
FDA warns Livonia, MI-based Purolea Cosmetics Lab about CGMP and other violations in its production of finished drugs as a contractor.
FDA warns Philadelphia, PA-based Medical Products Laboratories about CGMP violations in its manufacturing of unapproved new drugs.
FDA warns Livonia, MI-based Purolea Cosmetics Lab about CGMP and other violations in its production of finished drugs as a contractor.
FDA has issued a reminder to more than 2,200 clinical trial sponsors and researchers, urging them to comply with federal requirements to publicly report study results on ClinicalTrials.gov, amid concerns about widespread underreporting and potential bias in the scientific record. The agency said the outreach, conducted 3/
A panel of industry leaders, policy experts, and FDA say broader adoption of external control arms in oncology drug development will depend on improved data quality, closer collaboration with regulators and clearer expectations around evidentiary standards.
