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March 15, 2019
The agency published guidance to help with the development of enrichment strategist for clinical investigations of drug and biologic effectiveness.
FDA sent a warning letter to Hospira Healthcare India Pvt. Ltd. for CGMP violations including data integrity issues.
March 13, 2019
The FDA planned budget features added funds allotted to improved oversight of drugs, biologics, and medical devices.
FDA sent a warning letter to Jubilant Life Sciences after investigators found CGMP violations.
March 12, 2019
A federal court ordered Guardian Pharmacy Services to stop producing compounded drugs.
March 08, 2019
The Regulatory Affairs Professional Society (RAPS) has unveiled the details of its inaugural European regulatory conference, RAPS Regulatory Conference-Europe 2019.
The agency sent a warning letter to ANDAPharm, LLC after inspectors found the company’s cleaning and stability testing procedures were inadequate.
OSE Immunotherapeutics has been granted authorization to commence a Phase I clinical trial for checkpoint inhibitor BI 765063 (previously OSE-172).
March 07, 2019
Hetero Labs recalls losartan potassium tablets due to presence of N-Nitroso-N-methyl-4-aminobutyric acid.
March 06, 2019
Gottlieb’s tenure included record new drug approvals and steps taken to curb opioid abuse.