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401. Manufacturing, supply chain, and drug and biological product inspections during COVID-19 public health emergency: questions and answers

Publication:

[Silver Spring, MD] : Center for Drug Evaluation and Research, May 17, 2021

Subject(s):

Biological Products
COVID-19
Drug Industry
Quality Control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

402. Administrative rulemaking

Author(s):

Berry, Melissa D, author

Publication:

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

Subject(s):

Health Care Reform -- legislation & jurisprudence
Health Insurance Exchanges -- legislation & jurisprudence
Insurance, Health -- legislation & jurisprudence
Legislation, Medical
COVID-19
Health Information Interoperability
Medicaid -- legislation & jurisprudence
Medicare -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States.

403. Principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation: guidance for industry and Food and Drug Administration staff, and other stakeholders

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, January 26, 2022

Subject(s):

Device Approval
Patient Reported Outcome Measures
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

404. Q3C(R8) impurities: guidance for residual solvents

Publication:

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

Subject(s):

Drug Contamination
Solvents -- chemistry
Solvents -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

405. 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

406. Manufacture of blood components using a pathogen reduction device in blood establishments: questions and answers

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, November 2021

Subject(s):

Blood Banks
Blood Component Transfusion -- standards
Blood Safety
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

407. Surgical staplers and staples for internal use: labeling recommendations : guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, October 8, 2021

Subject(s):

Product Labeling
Surgical Staplers
Sutures
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

408. Reporting amount of listed drugs and biological products technical conformance guide

Publication:

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

Subject(s):

Biological Products
Drug Industry
Drug Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

409. Interpreting sameness of gene therapy products under the orphan drug regulations

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, September 2021

Subject(s):

Genetic Therapy
Orphan Drug Production -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

410. 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

411. Questions and answers on biosimilar development and the BPCI Act

Publication:

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

Subject(s):

Biosimilar Pharmaceuticals
Drug Development
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States.

412. Methods used to enable interoperability among U.S. non-federal acute care hospitals in 2017

Author(s):

Johnson, Christian, MPH, author
Pylypchuk, Yuriy, author
Patel, Vaishali, author

Publication:

Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, December 2018

Subject(s):

Electronic Health Records
Health Information Interoperability
Hospitals
Information Dissemination -- methods
United States
United States. Department of Health and Human Services

413. Reducing microbial food safety hazards in the production of seed for sprouting: guidance for industry

Publication:

College Park, MD : Center for Food Safety and Applied Nutrition, May 2022

Subject(s):

Food Safety
Foodborne Diseases -- prevention & control
Seeds
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

414. Assessing user fees under the Generic Drug User Fee Amendments of 2017

Publication:

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

Subject(s):

Drug Industry -- legislation & jurisprudence
Drugs, Generic -- economics
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

415. Investigating out-of specification (OOS) test results for pharmaceutical production

Publication:

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

Subject(s):

Drug Industry -- legislation & jurisprudence
Pharmaceutical Solutions
Technology, Pharmaceutical
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

416. General principles for evaluating the human food safety of new animal drugs used in food-producing animals

Publication:

[Silver Spring, MD] : Center for Veterinary Medicine, May 2022

Subject(s):

Agriculture -- legislation & jurisprudence
Food Safety
Livestock
Poultry
Veterinary Drugs
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

417. Feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with Type 2 Diabetes Mellitus: guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, May 6, 2022

Subject(s):

Clinical Studies as Topic
Diabetes Mellitus, Type 2 -- drug therapy
Glycemic Control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

418. Electronic submission of IND safety reports: technical conformance guide

Publication:

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

Subject(s):

Digital Technology
Drug Approval
Investigational New Drug Application
Safety
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

419. Technical performance assessment of quantitative imaging in radiological device premarket submissions: guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, June 16, 2022

Subject(s):

Device Approval
Technology, Radiologic -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

420. Appendix I (B) to the ICH E2B(R3) ICSRs implementation guide: backwards and forwards compatibility

Publication:

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

Subject(s):

Clinical Coding
Databases, Pharmaceutical
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

421. Electromagnetic compatibility (EMC) of medical devices: guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, June 6, 2022

Subject(s):

Electromagnetic Fields
Equipment Design -- standards
Equipment Safety -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

422. Recommendations to reduce the possible risk of transmission of Creutzfeldt-Jakob disease and variant Creutzfeldt-Jakob disease by blood and blood components

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, May 2022

Subject(s):

Blood Component Transfusion -- legislation & jurisprudence
Creutzfeldt-Jakob Syndrome -- prevention & control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

423. Safety considerations for container labels and carton labeling design to minimize medication errors

Publication:

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

Subject(s):

Drug Labeling -- legislation & jurisprudence
Medication Errors -- prevention & control
Patient Safety
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

424. Supplements for approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions 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 Devices and Radiological Health, May 2022

Subject(s):

Compassionate Use Trials -- legislation & jurisprudence
COVID-19
Device Approval -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

425. Advanced prostate cancer: developing gonadotropin-releasing hormone analogues

Publication:

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

Subject(s):

Drug Development -- legislation & jurisprudence
Gonadotropin-Releasing Hormone
Prostatic Neoplasms -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

426. Importation of prescription drugs final rule: questions and answers

Publication:

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

Subject(s):

Prescription Drugs -- standards
Prescription Drugs -- supply & distribution
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

427. E2B(R3) electronic transmission of Individual Case Safety Reports (ICSRs) implementation guide: data elements and message specification

Publication:

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

Subject(s):

Adverse Drug Reaction Reporting Systems
Drug and Narcotic Control
Electronic Mail
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

428. Electronic health information: HHS needs to improve communications for breach reporting : report to congressional committees

Publication:

Washington, DC : United States Government Accountability Office, May 2022

Subject(s):

Electronic Health Records -- standards
Government Regulation
Health Records, Personal -- ethics
United States
United States. Department of Health and Human Services
United States.

429. COVID-19: Pandemic lessons highlight need for public health situational awareness network : report to congressional addressees

Publication:

Washington, DC : United States Government Accountability Office, June 2022

Subject(s):

Awareness
Civil Defense -- organization & administration
COVID-19
Government Regulation
Pandemics -- legislation & jurisprudence
United States
United States. Department of Health and Human Services

430. Providing regulatory submissions in electronic format: standardized study data

Publication:

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

Subject(s):

Data Management
Drug Approval
Government Regulation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

431. Bispecific antibody development programs

Publication:

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

Subject(s):

Antibodies, Bispecific
Drug Development
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

432. Emergency Use Authorization for vaccines to prevent COVID-19

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, May 25, 2021

Subject(s):

COVID-19 Vaccines
Government Regulation
Vaccine Development
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

433. ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin

Publication:

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

Subject(s):

Chemistry Techniques, Synthetic
DNA, Ribosomal
Drug Approval
Drugs, Generic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

434. Peripheral vascular atherectomy devices: premarket notification [510(k)] submissions : guidance for industry and Food and Drug Administration staff

Publication:

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

Subject(s):

Atherectomy -- instrumentation
Device Approval
Equipment Safety
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

435. Q12 technical and regulatory considerations for pharmaceutical product lifecycle management: annexes

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

436. S11 nonclinical safety testing in support of development of pediatric pharmaceuticals

Publication:

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

Subject(s):

Drug Compounding
Drug Industry
Pediatrics
Pharmaceutical Preparations
Quality Control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

437. Investigational COVID-19 convalescent plasma

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, January 7, 2022

Subject(s):

COVID-19 -- therapy
Immunization, Passive
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

438. Arthroscopy pump tubing sets intended for multiple patient use - Premarket Notification (510(k)) submissions: guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, December 23, 2021

Subject(s):

Arthroscopy -- instrumentation
Device Approval
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

439. Interoperability among office-based physicians in 2015 and 2017

Author(s):

Patel, Vaishali, author
Pylypchuk, Yuriy, author
Parasrampuria, Sonal, author
Kachay, Lolita, author

Publication:

Washington, D.C. : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, May 2019

Subject(s):

Electronic Health Records -- trends
Health Information Interoperability -- trends
Information Dissemination
Practice Patterns, Physicians' -- trends
United States
United States. Department of Health and Human Services

440. Trends in individuals' access, viewing and use of online medical records and other technology for health needs: 2017-2018

Author(s):

Patel, Vaishali, author
Johnson, Christian, MPH, author

Publication:

Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, May 2019

Subject(s):

Electronic Health Records -- statistics & numerical data
Electronic Health Records -- trends
Mobile Applications
Smartphone
United States
United States. Department of Health and Human Services

441. Access and use of electronic health information by individuals with cancer: 2017-2018

Author(s):

Johnson, Christian, MPH, author
Krakow, Melinda, author
Patel, Vaishali, author

Publication:

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

Subject(s):

Electronic Health Records -- statistics & numerical data
Facilities and Services Utilization -- statistics & numerical data
Health Services Accessibility -- statistics & numerical data
Neoplasms
United States
United States. Department of Health and Human Services

442. Conduct of clinical trials of medical products during the COVID-19 public health emergency: guidance for industry, investigators, and institutional review boards

Publication:

[Silver Spring, MD] : Center for Drug Evaluation and Research, August 30, 2021

Subject(s):

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

443. State of Interoperability among U.S. non-federal acute care hospitals in 2018

Author(s):

Pylypchuk, Yuriy, author
Johnson, Christian, MPH, author
Patel, Vashali, author

Publication:

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

Subject(s):

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

444. COVID-19: HHS should clarify agency roles for emergency return of U.S. citizens during a pandemic : report to Congressional addressees

Publication:

Washington, DC : United States Government Accountability Office, April 2021

Subject(s):

Disaster Planning -- legislation & jurisprudence
Government Regulation
Travel-Related Illness
United States
United States. Department of Health and Human Services

445. Medicaid: HHS’s preliminary analyses offer incomplete picture of behavioral health demonstration’s effectiveness : report to Congressional requesters

Publication:

Washington, DC : United States Government Accountability Office, May 2021

Subject(s):

Behavioral Medicine -- economics
Community Mental Health Services -- legislation & jurisprudence
Government Regulation
Medicaid -- economics
Medicare -- economics
United States
United States. Department of Health and Human Services

446. Maternal mortality and morbidity: additional efforts needed to assess program data for rural and underserved areas : report to the Committee on Ways and Means, House of Representatives

Publication:

Washington, DC : United States Government Accountability Office, April 2021

Subject(s):

Government Regulation
Maternal Mortality
Medically Underserved Area
Pregnancy Complications -- epidemiology
United States
United States. Department of Health and Human Services
Centers for Disease Control and Prevention (U.S.)

447. Graduate medical education: programs and residents increased during transition to single accreditor; distribution largely unchanged : report to Congressional requesters

Publication:

Washington, DC : United States Government Accountability Office, April 2021

Subject(s):

Accreditation -- standards
Education, Medical, Graduate -- economics
Government Regulation
United States
United States. Department of Health and Human Services

448. Nonclinical testing of orally inhaled nicotine-containing drug products

Publication:

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

Subject(s):

Administration, Inhalation
Tobacco Use Cessation Devices
Toxicity Tests
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

449. Formal meetings between FDA and ANDA applicants of complex products under GDUFA

Publication:

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

Subject(s):

Drug Approval
Drug Development
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

450. Notifying CDRH of a permanent discontinuance or interruption in manufacturing of a device under Section 506J of the FD&C Act during the 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, November 2020

Subject(s):

Equipment and Supplies
Manufacturing Industry
Medical Device Legislation
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration