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Start Over Dates by Range 2000 and later ✖Remove constraint Dates by Range: 2000 and later Publication Year 2020 to 2021 ✖Remove constraint Publication Year: <span class="from" data-blrl-begin="2020">2020</span> to <span class="to" data-blrl-end="2021">2021</span>

1191. Recommendations for dual 510(k) and CLIA waiver by application studies: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, February 26, 2020
Subject(s):
Clinical Laboratory Techniques
Device Approval
Reagent Kits, Diagnostic
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

1199. 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.