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351. Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions 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, May 2020

Subject(s):

Device Approval
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

352. COVID-19: developing drugs and biological products for treatment or prevention

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, February 2021

Subject(s):

Biological Products
COVID-19 Drug Treatment
COVID-19 -- prevention & control
Drug Industry
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

353. Postmarketing adverse event reporting for medical products and dietary supplements during a pandemic

Publication:

Silver Spring, MD : Office of Counterterrorism and Emerging Threats, May 2020

Subject(s):

Dietary Supplements -- adverse effects
Drug-Related Side Effects and Adverse Reactions
Equipment Design -- adverse effects
Equipment Safety
Product Surveillance, Postmarketing
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

354. Opioid use disorder: endpoints for demonstrating effectiveness of drugs for treatment

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, October 2020

Subject(s):

Analgesics, Opioid
Opioid-Related Disorders -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

355. 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

356. Submission of plans for cigarette packages and cigarette advertisements (revised)

Publication:

Silver Spring, MD : Center for Tobacco Products, July 2021

Subject(s):

Cigarette Smoking -- adverse effects
Cigarette Smoking -- prevention & control
Product Packaging
Tobacco Products -- adverse effects
Tobacco Products -- supply & distribution
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

357. Resuming normal drug and biologics manufacturing operations during the COVID-19 public health emergency

Publication:

[Silver Spring, MD] : Center for Drug Evaluation and Research, September 2020

Subject(s):

Biological Products
Drug Industry
Manufacturing and Industrial Facilities
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

358. 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

359. 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

360. 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

361. Cancer clinical trial eligibility criteria: brain metastases

Publication:

Silver Spring, MD : Food and Drug Administration, Oncology Center of Excellence, July 2020

Subject(s):

Brain Neoplasms
Clinical Trials as Topic
Eligibility Determination
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

362. 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

363. 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

364. Cutaneous electrodes for recording purposes--performance criteria for safety and performance based pathway: guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, August 14, 2020

Subject(s):

Electrodes
Equipment Design
Equipment Safety
Electrocardiography
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

365. 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

366. 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

367. 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

368. Temporary policy regarding preventive controls and FSVP food supplier verification onsite audit requirements during the COVID-19 public health emergency: guidance for industry

Publication:

[Silver Spring, MD] : Center for Food Safety and Applied Nutrition, June 2020

Subject(s):

Animal Feed -- supply & distribution
Food Handling
Food Supply
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

369. 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

370. 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

371. Pediatric study plans: content of and process for submitting initial pediatric study plans and amended initial pediatric study plans

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, July 2020

Subject(s):

Clinical Studies as Topic
Drug Development
Pediatrics
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

372. Community-acquired bacterial pneumonia: developing drugs for treatment

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, June 2020

Subject(s):

Community-Acquired Infections
Drug Development
Pneumonia, Bacterial -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

373. 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

374. Policy for temporary compounding of certain alcohol-based hand sanitizer products during the public health emergency: immediately in effect guidance for industry

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, February 10, 2021

Subject(s):

Drug Compounding -- methods
Drug Compounding -- standards
Ethanol
Hand Sanitizers
Methanol
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

375. 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

376. Classification of posterior cervical screw systems: small entity compliance guide : guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, May 4, 2020

Subject(s):

Bone Screws
Cervical Vertebrae
Classification
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

377. Required warnings for cigarette packages and advertisements: small entity compliance guide (revised)

Publication:

Silver Spring, MD : Center for Tobacco Products, July 2021

Subject(s):

Cigarette Smoking -- adverse effects
Cigarette Smoking -- prevention & control
Product Packaging
Tobacco Products -- adverse effects
Tobacco Products -- supply & distribution
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

378. Certificates of confidentiality: guidance for sponsors, sponsor-investigators, researchers, industry, and food and drug administration staff

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research September 2020

Subject(s):

Biomedical Research
Confidentiality
Privacy
Research Subjects
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

379. 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 Treatment
COVID-19 -- prevention & control
Outpatients
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

380. 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

381. Control of nitrosamine impurities in human drugs

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, February 2021

Subject(s):

Drug Contamination -- prevention & control
Nitrosamines
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

382. 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

383. 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

384. 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

385. Hospital capabilities to enable patient electronic access to health information: 2019

Author(s):

Johnson, Christian, MPH (based on t.p. from bib 9918317680806676), author
Barker, Wesley, author

Publication:

Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, June 2021

Subject(s):

Access to Information
Electronic Health Records
Hospitals -- statistics & numerical data
Patient Portals -- statistics & numerical data
United States
United States. Department of Health and Human Services

386. Individuals' access and use of patient portals and smartphone health apps: 2020

Author(s):

Johnson, Christian, MPH (based on t.p. from bib 9918317682006676), author
Richwine, Chelsea, author
Patel, Vaishali, author

Publication:

Washington, DC : Office of the National Coordinator for Health Information Technology, September 2021

Subject(s):

Facilities and Services Utilization -- statistics & numerical data
Mobile Applications
Patient Portals
Smartphone
Physician's Role
United States
United States. Department of Health and Human Services

387. Challenges to public health reporting experienced by non-federal acute care hospitals: 2019

Author(s):

Richwine, Chelsea, author
Marshall, Carmelita, author
Jensen, Christian, 1833-1916, author
Patel, Vaishali, author

Publication:

Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, September 2021

Subject(s):

Health Information Interoperability
Hospitals
Information Dissemination
Mandatory Reporting
Public Health
Public Health Surveillance
COVID-19
Health Facility Size
State Government
United States
United States. Department of Health and Human Services

388. Remote interactive evaluations of drug manufacturing and bioresearch monitoring facilities during the COVID-19 public health emergency

Publication:

[Silver Spring, MD] : Center for Drug Evaluation and Research, April 2021

Subject(s):

Consumer Product Safety
Drug Industry
Pharmaceutical Research
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

389. Testing and labeling medical devices for safety in the magnetic resonance (MR) environment: guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, May 20, 2021

Subject(s):

Device Approval
Equipment Safety
Magnetic Resonance Imaging -- instrumentation
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

390. Q12 technical and regulatory considerations for pharmaceutical product lifecycle management

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, May 2021

Subject(s):

Drug Industry
Quality Control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

391. 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):

Biological Products -- chemistry
Biological Products -- supply & distribution
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

392. Principles of premarket pathways for combination products: guidance for industry and FDA Staff

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, January 2022

Subject(s):

Biological Products
Device Approval
Drug Approval
Government Regulation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

393. Providing regulatory submissions in alternate electronic format

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, July 2021

Subject(s):

Biological Products
Drug Approval
Drug Development
Electronic Mail
Government Regulation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

394. Technical specifications for submitting clinical trial data sets for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH)

Publication:

[Silver Spring, MD] : Center for Drug Evaluation and Research, January 2022

Subject(s):

Clinical Trials as Topic
Non-alcoholic Fatty Liver Disease -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

395. Development and submission of near infrared analytical procedures

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, August 2021

Subject(s):

Spectroscopy, Near-Infrared -- methods
Spectroscopy, Near-Infrared -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

396. Variation in methods for health information management among U.S. substance abuse treatment centers: 2017

Author(s):

Barker, Wesley, author
Christian Johnson, MPH, author

Publication:

Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, July 2020

Subject(s):

Electronic Health Records -- statistics & numerical data
Health Information Management -- methods
Information Dissemination -- methods
Substance Abuse Treatment Centers -- statistics & numerical data
United States
United States. Department of Health and Human Services

397. State of interoperability among major U.S. cities

Author(s):

Pylypchuk, Yuriy, author
Jensen, Christian, 1833-1916, author

Publication:

Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, October 2020

Subject(s):

Cities -- statistics & numerical data
Electronic Health Records
Health Information Interoperability -- statistics & numerical data
Hospitals, Urban -- statistics & numerical data
Information Dissemination
United States
United States. Department of Health and Human Services

398. Use of certified health IT and methods to enable interoperability by U.S. non-federal acute care hospitals: 2019

Author(s):

Johnson, Christian, MPH (based on t.p. from bib 9918317680206676), author
Pylypchuk, Yuriy, author

Publication:

Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, February 2021

Subject(s):

Electronic Health Records
Health Information Interoperability -- trends
Hospitals
Information Dissemination
Health Information Interoperability -- legislation & jurisprudence
United States
United States. Department of Health and Human Services

399. COVID-19 container closure system and component changes: glass vials and stoppers

Publication:

[Silver Spring, MD] : Center for Drug Evaluation and Research, March 2021

Subject(s):

Drug Packaging
Glass
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

400. Delivery reform

Author(s):

Raduege, Tammy J., author

Publication:

[Toronto, Ontario] : Thomson Reuters, 20-December-2021

Subject(s):

Delivery of Health Care -- organization & administration
Health Care Reform -- legislation & jurisprudence
Accountable Care Organizations
Electronic Health Records
Federal Government
Maternal Health
Medicare
State Government
United States
United States. Department of Health and Human Services
United States.
Centers for Medicare & Medicaid Services (U.S.)