Drugs
Patents and Exclusivities for Generic Drug Products
- Capt. Martin Shimer, Office of Generic Drugs
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CDER Conversations Drug being incorrectly prescribed for rare liver disease
- Risk of serious liver injury and death
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FDA Drug Safety Communication: FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease Use caution combining opioid addiction drugs
- Harm caused by untreated opioid addiction usually outweighs side effects
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FDA Drug Safety Communication: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks Last chance to register for free event
- Conference offers in-person and virtual attendance
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FDA Small Business Regulatory Education for Industry (REdI): Fall Conference September 27-28, 2017
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News and Announcements
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to promote the safe adoption of medication-assisted treatment for opioid addiction FDA is Advancing the Goals of the Orphan Drug Act - "Continuous Manufacturing” – Common Guiding Principles Can Help Ensure Progress
Drug Safety
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