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6321. Assessing COVID-19-related symptoms in outpatient adult and adolescent subjects in clinical trials of drugs and biological products for COVID-19 prevention or treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
Subject(s):: Clinical Trials as Topic
COVID-19 -- drug therapy
COVID-19 -- prevention & control
Outpatients
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6322. ANDA submissions: amendments and requests for final approval to tentatively approved ANDAs

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
Subject(s):: Drug Approval
Drug Industry
Drugs, Generic
Therapeutic Equivalency
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6323. Importation of certain FDA approved human prescription drugs, including biological products, and combination products under section 801(d)(1)(b) of the Federal Food, Drug, and Cosmetic Act

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
Subject(s):: Biological Products
Drug Labeling
Prescription Drugs
Counterfeit Drugs
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6324. Recognition and withdrawal of voluntary consensus standards: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 15, 2020
Subject(s):: Consensus
Equipment and Supplies -- standards
Voluntary Programs -- standards
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6325. The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 25, 2020
Subject(s):: Accreditation
Equipment and Supplies
Materials Testing
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6326. Basic safety and essential performance of medical electrical equipment, medical electrical systems, and laboratory medical equipment: standards specific information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program : guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 25, 2020
Subject(s):: Accreditation
Electricity
Equipment Safety
Equipment and Supplies
Mechanical Tests
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6327. Biocompatibility testing of medical devices: standards specific information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program : guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 25, 2020
Subject(s):: Accreditation
Equipment and Supplies
Materials Testing -- standards
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6328. Blood glucose monitoring test systems for prescription point-of-care use: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2020
Subject(s):: Blood Glucose
Equipment Safety
Point-of-Care Testing
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6329. Breast implants: certain labeling recommendations to improve patient communication : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2020
Subject(s):: Breast Implants
Equipment Safety
Product Labeling
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6330. Self-monitoring blood glucose test systems for over-the-counter use: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2020
Subject(s):: Blood Glucose Self-Monitoring
Device Approval
Equipment Safety
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

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