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FDA publishes draft guidances on developing non-opioid analgesics for chronic pain and facilitating a benefit/risk analysis for op...[ Price : $8.95]
A CDER Office of Prescription Drug Promotion Notice of Violation cites a misleading BeOne Medicine TV spot for its leukemia drug B...[ Price : $8.95]
Analysts and investors interviewed by Reuters see a short-term positive reaction to the departure of Marty Makary, but caution tha...[ Price : $8.95]
FDA releases a draft guidance detailing how the agency will evaluate the benefits and risks of new opioid analgesic drugs, emphasi...[ Price : $8.95]
A King & Spalding legal analysis examines FDAs newly announced pilot program for one-day inspectional assessments, suggesting it m...[ Price : $8.95]
FDA warns Israels Naveh Pharma and Atlanta, GA-based Bigdam about selling unapproved new drugs that are adulterated by CGMP violat...[ Price : $8.95]
FDA commissioner Marty Makary hands in his resignation after a week of mounting speculation that the Trump Administration was prep...[ Price : $8.95]
Stakeholders ask FDA to clarify its draft guidance on responses to an FDA-483.