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4196. Slowly progressive, low-prevalence rare diseases with substrate deposition that result from single enzyme defects: providing evidence of effectiveness for replacement or corrective therapies

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2020
Subject(s):
Drug Development -- standards
Drugs, Investigational
Rare Diseases -- drug therapy
Metabolism, Inborn Errors -- drug therapy
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4198. Policy for certain REMS requirements during the COVID-19 public health emergency: guidance for industry and health care professionals

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2020
Subject(s):
Coronavirus Infections -- epidemiology
Pandemics
Risk Evaluation and Mitigation
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4200. Enforcement policy for sterilizers, disinfectant devices, and air purifiers during the coronavirus disease 2019 (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, March 2020
Subject(s):
Air Filters
Coronavirus Infections -- epidemiology
Disinfection -- instrumentation
Pandemics
Sterilization -- instrumentation
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.