Antibiotic Pipeline Profile: Balancing Broad Spectrum And Limited Use
Executive Summary
Broad spectrum antibiotic candidates for hospital use dominate the late-stage pipeline under the US FDA's Qualified Infectious Disease Product (QIDP) program, despite efforts to target limited populations of patients and pathogens.
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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.
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