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704. Enforcement policy for viral transport media during the Coronavirus disease 2019 (COVID-19) public health emergency: guidance for commercial manufacturers, clinical laboratories, and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, Office of Product Evaluation and Quality, July 2020
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

716. Temporary policy for compounding of certain drugs for hospitalized patients by pharmacy compounders not registered as outsourcing facilities during the COVID-19 public health emergency (revised)

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, Office of Compliance May 21, 2020
Subject(s):
Drug Compounding -- methods
Hospitalization
Outsourced Services
Pharmacies
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

719. Enforcement policy for extracorporeal membrane oxygenation and cardiopulmonary bypass devices 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, Office of Product Evaluation and Quality April 2020
Subject(s):
Cardiopulmonary Bypass -- instrumentation
Extracorporeal Membrane Oxygenation -- instrumentation
COVID-19 -- therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

727. Civil money penalties relating to the ClinicalTrials.gov data bank: guidance for responsible parties, submitters of certain applications and submissions to FDA, and FDA staff

Publication:
Silver Spring, MD : United States Food and Drug Administration, Office of Good Clinical Practice. August 2020
Subject(s):
Clinical Trials as Topic
Databases as Topic
Data Management -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

731. Enforcement policy for remote ophthalmic assessment and monitoring devices 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, Office of Product Evaluation and Quality 2020
Subject(s):
Remote Consultation
Telemedicine -- instrumentation
Tonometry, Ocular -- instrumentation
Vision Tests -- instrumentation
Wireless Technology -- instrumentation
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

732. Temporary policy regarding non-standard PPE practices for sterile compounding by pharmacy compounders not registered as outsourcing facilities during the COVID-19 public health emergency

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, Office of Compliance, April 2020
Subject(s):
Drug Compounding -- methods
Personal Protective Equipment -- supply & distribution
COVID-19
Sterilization -- methods
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

733. Policy for the temporary use of portable cryogenic containers not in compliance with 21 CFR 211.94(e)(1) for oxygen and nitrogen during the COVID-19 public health emergency

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, April 2020
Subject(s):
Nitrogen -- supply & distribution
Oxygen -- supply & distribution
COVID-19
Nitrogen -- therapeutic use
Oxygen -- therapeutic use
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

734. Providing regulatory submissions for medical devices in electronic format: submissions under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, July 15, 2020
Subject(s):
Electronic Data Processing -- legislation & jurisprudence
Legislation, Drug
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

735. Clinical investigations for prostate tissue ablation devices: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, July 15, 2020
Subject(s):
Clinical Studies as Topic
High-Intensity Focused Ultrasound Ablation
Prostate -- surgery
Prostatic Neoplasms -- prevention & control
Prostatic Neoplasms -- surgery
Therapies, Investigational
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

736. Unique device identification: policy regarding compliance dates for class I and unclassified devices and certain devices requiring direct marking : immediately in effect guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, July 1, 2020
Subject(s):
Equipment and Supplies -- standards
Medical Device Legislation
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

739. Institutional review board (IRB) review of individual patient expanded access requests for investigational drugs and biological products during the COVID-19 public health emergency: guidance for IRBs and clinical investigators

Publication:
[Silver Spring, MD] : Oncology Center of Excellence, June 2020
Subject(s):
Biological Products -- therapeutic use
COVID-19 Drug Treatment
Drugs, Investigational
Ethics Committees, Research
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

752. Enforcement policy for non-invasive remote monitoring devices used to support patient monitoring during the coronavirus disease 2019 (COVID-19) public health emergency (revised): guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, October 2020
Subject(s):
COVID-19
Monitoring, Physiologic
Remote Sensing Technology
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

758. COVID-19 public health emergency: general considerations for pre-IND meeting requests for COVID-19 related drugs and biological products : guidance for industry and investigators

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, May 2020
Subject(s):
Biological Products
COVID-19 Drug Treatment
Drug Approval
Drug Industry
Drugs, Investigational
Drug Evaluation, Preclinical
Investigational New Drug Application
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

761. Policy for coronavirus disease-2019 tests during the public health emergency (revised): immediately in effect guidance for clinical laboratories, commercial manufacturers, and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, May 11, 2020
Subject(s):
Clinical Laboratory Techniques
COVID-19 Serological Testing
COVID-19 Testing
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

765. Enforcement policy for face masks and respirators during the coronavirus disease (COVID-19) public health emergency (revised): guidance for industry and food and drug administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, May 2020
Subject(s):
COVID-19 -- prevention & control
Masks
N95 Respirators
Personal Protective Equipment
Respiratory Protective Devices
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

780. 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

781. 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

785. Use of International Standard ISO 10993-1: "Biological evaluation of medical devices - part 1 : evaluation and testing within a risk management process" : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 4, 2020
Subject(s):
Device Approval
Equipment Failure
Equipment Safety
Equipment and Supplies -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

791. Medicaid and CHIP eligibility, enrollment, and cost sharing policies as of January 2020: findings from a 50-state survey

Author(s):
Brooks, Tricia, author
Roygardner, Lauren, author
Artiga, Samantha, author
Pham, Olivia, author
Dolan, Rachel, author
Publication:
San Francisco, CA : Henry J. Kaiser Family Foundation, March 2020
Subject(s):
Cost Sharing
Eligibility Determination
Insurance Coverage -- statistics & numerical data
Medicaid -- statistics & numerical data
State Government
United States
United States.
State Children's Health Insurance Program (U.S.)

794. Digital health technologies as an adjunct to medication assisted therapy for opioid use disorder: final evidence report and meeting summary

Author(s):
Tice, Jeffrey A., author
Whittington, Melanie D., author
Fluetsch, Noemi, author
Zapata, Lorenzo Villa, author
Mendola, Nicolas D., author
Chapman, Rick M., author
Campbell, Jonathan D., author
Pearson, Steven D., author
Bradt, Pamela, author
Publication:
[Boston, Massachusetts] : Institute for Clinical and Economic Review, December 11, 2020
Subject(s):
Behavior Therapy
Digital Technology
Opiate Substitution Treatment
Opioid-Related Disorders -- therapy
United States

795. Supervised injection facilities and other supervised consumption sites: effectiveness and value : final report

Author(s):
Armbrecht, Eric, author
Guzauskas, Greg, author
Hansen, Ryan, author
Pandey, Rajshree, author
Fazioli, Katherine, author
Chapman, Rick M., author
Pearson, Steven D., author
Rind, David M., author
Publication:
[Boston, Massachusetts] : Institute for Clinical and Economic Review, January 8, 2021
Subject(s):
Harm Reduction
Needle-Exchange Programs
Opiate Overdose -- prevention & control
Opioid-Related Disorders -- therapy
United States

797. Nadofaragene firadenovec and oportuzumab monatox for BCG-unresponsive, non-muscle invasive bladder cancer: effectiveness and value : final report

Author(s):
Atlas, Steven J., author
Touchette, Daniel R., author
Beinfeld, Molly, author
McKenna, Avery, author
Joshi, Mrinmayee, author
Chapman, Rick M., author
Pearson, Steven D., author
Rind, David M., author
Publication:
[Boston, Massachusetts] : Institute for Clinical and Economic Review, January 15, 2021
Subject(s):
Antibodies, Monoclonal -- therapeutic use
Urinary Bladder Neoplasms -- drug therapy
Genetic Vectors -- therapeutic use
United States