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US FDA Progress Report Highlights Biomarkers, Continuous Manufacturing, Antibiotic Testing

Executive Summary

Agency documents its regulatory science accomplishments to advance product development and manufacturing and ensure the safety and effectiveness of marketed products.

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Disease-Specific Drug Development Guidances Coming From US FDA In 2018

Alzheimer's disease, amyotrophic lateral sclerosis, migraine, and opioid dependence are among conditions that will get drug development guides from FDA; other guidances will address ANDA bioequivalence studies, shared REMS, and continuous manufacturing.

Disease-Specific Drug Development Guidances Coming From US FDA In 2018

Alzheimer's disease, amyotrophic lateral sclerosis, migraine, and opioid dependence are among conditions that will get drug development guides from FDA; other guidances will address ANDA bioequivalence studies, shared REMS, and continuous manufacturing.

Sarepta's Eteplirsen Approved After Contentious Internal FDA Debate

CDER Director Woodcock grants accelerated approval after FDA Commissioner Califf refuses to overturn her finding that the drug's effect on dystrophin is reasonably likely to predict clinical benefit in Duchenne muscular dystrophy.

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