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3631. Non-clinical and clinical investigation of devices used for the treatment of benign prostatic hyperplasia (BPH): guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, December 27, 2021
Subject(s):
Device Approval
Prostatic Hyperplasia -- therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

3636. Pain points along the journey from skilled nursing facility to home: patient and caregiver perspectives

Author(s):
Kothari, Pooja, author
Mallon, Kevin, author
Rogut, Lynn, author
Guzik, Joan, author
Publication:
[New York, New York] : United Hospital Fund, October 2021
Subject(s):
Home Nursing
Patient Discharge
Patient Transfer
Skilled Nursing Facilities
Transitional Care
COVID-19
Patient Education as Topic
Surveys and Questionnaires
New York
United States

3637. CMC postapproval manufacturing changes for specified biological products to be documented in annual reports

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, December 2021
Subject(s):
Annual Reports as Topic
Biological Products -- standards
Biological Products -- supply & distribution
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

3638. Policy for coronavirus disease-2019 tests during the public health emergency (revised): guidance for developers and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, November 15, 2021
Subject(s):
COVID-19 Serological Testing -- standards
COVID-19 Testing -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

3639. Enforcement policy for viral transport media during the coronavirus disease 2019 (COVID19) public health emergency (revised): guidance for commercial manufacturers, clinical laboratories, and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, November 2021
Subject(s):
Culture Media
Specimen Handling
Transportation
Virus Diseases
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration