CDER New November 25, 2015

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What's New on the FDA Drugs Site

November 24, 2015

• Certification Process for Designated Medical Gases Guidance for Industry (PDF - 279KB)
• FDA Adverse Event Reporting System (FAERS) Statistics (updated)
  • Reports Received and Reports Entered into FAERS by Year (updated)
  • FAERS Domestic and Foreign Reports by Year (updated)
  • FAERS Reporting by Healthcare Providers and Consumers by Year (updated)
  • FAERS Reporting by Patient Outcomes by Year (updated)
• FDA approves Opdivo (nivolumab) to treat advanced form of kidney cancer
• FDA approves Portrazza (necitumumab) to treat advanced squamous non-small cell lung cancer
• FDA Drug Safety Communication (Spanish): La FDA informa de casos poco comunes de hipotiroidismo en bebés que recibieron medios de contraste yodados para espectroscopía médica
• FDA Drug Shortages
  • Haloperidol Lactate Injection (Updated - Currently in Shortage)
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)