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201. Medicaid eligibility, enrollment, and renewal processes and systems study: case study summary report--Arizona

Author(s):
Zylla, Emily, author
Au-Yeung, Caroline, author
Lukanen, Elizabeth, author
Worrall, Christina, author
Publication:
[Minneapolis, Minnesota] : State Health Access Data Assistance Center, October 19, 2018
Subject(s):
Eligibility Determination -- organization & administration
Medicaid -- statistics & numerical data
Electronic Data Processing
Federal Government
Income
Patient Navigation
State Government
Humans
Arizona
United States
United States. Department of Health and Human Services.
United States.
State Children's Health Insurance Program (U.S.)

202. Medicaid eligibility, enrollment, and renewal processes and systems study: case study summary report--Colorado

Author(s):
Zylla, Emily, author
Au-Yeung, Caroline, author
Yukanen, Elizabeth, author
Worrall, Christina, author
Publication:
[Minneapolis, Minnesota] : State Health Access Data Assistance Center, October 19, 2018
Subject(s):
Eligibility Determination -- organization & administration
Medicaid -- statistics & numerical data
Electronic Data Processing
Income
Federal Government
Patient Navigation
State Government
Humans
Colorado
United States
United States. Department of Health and Human Services.
United States.
State Children's Health Insurance Program (U.S.)

203. Medicaid eligibility, enrollment, and renewal processes and systems study: case study summary report--Florida

Author(s):
Zylla, Emily, author
Au-Yeung, Caroline, author
Yukanen, Elizabeth, author
Worrall, Christina, author
Publication:
[Minneapolis, Minnesota] : State Health Access Data Assistance Center, October 19, 2018
Subject(s):
Eligibility Determination
Medicaid -- statistics & numerical data
Electronic Data Processing
Federal Government
Income
Patient Navigation
State Government
Humans
Florida
United States
United States. Department of Health and Human Services.
United States.
State Children's Health Insurance Program (U.S.)

204. Medicaid eligibility, enrollment, and renewal processes and systems study: case study summary report--Idaho

Author(s):
Zylla, Emily, author
Au-Yeung, Caroline, author
Yukanen, Elizabeth, author
Worrall, Christina, author
Publication:
[Minneapolis, Minnesota] : State Health Access Data Assistance Center, October 19, 2018
Subject(s):
Eligibility Determination -- organization & administration
Medicaid -- statistics & numerical data
Electronic Data Processing
Federal Government
Income
Patient Navigation
State Government
Humans
Idaho
United States
United States. Department of Health and Human Services.
United States.
State Children's Health Insurance Program (U.S.)

205. Medicaid eligibility, enrollment, and renewal processes and system study: case study summary report--New York

Author(s):
Zylla, Emily, author
Au-Yeung, Caroline, author
Yukanen, Elizabeth, author
Worrall, Christina, author
Publication:
[Minneapolis, Minnesota] : State Health Access Data Assistance Center, University of Minnesota, October 19, 2018
Subject(s):
Eligibility Determination -- organization & administration
Medicaid -- statistics & numerical data
Electronic Data Processing
Federal Government
Income
Patient Navigation
State Government
Humans
New York
United States
United States. Department of Health and Human Services.
United States.
State Children's Health Insurance Program (U.S.)

206. Medicaid eligibility, enrollment, and renewal processes and systems study: case study summary report--North Carolina

Author(s):
Zylla, Emily, author
Au-Yeung, Caroline, author
Yukanen, Elizabeth, author
Worrall, Christina, author
Publication:
[Minneapolis, Minnesota] : State Health Access Data Assistance Center, October 19, 2018
Subject(s):
Eligibility Determination -- organization & administration
Medicaid -- statistics & numerical data
Electronic Data Processing
Federal Government
Income
Patient Navigation
State Government
Humans
North Carolina
United States
United States. Department of Health and Human Services.
United States.
State Children's Health Insurance Program (U.S.)

207. Opioid use disorders: HHS needs measures to assess the effectiveness of efforts to expand access to medication-assisted treatment : report to majority leader, U.S. Senate

Publication:
Washington, DC : United States Government Accountability Office, October 2017
Subject(s):
Health Services Accessibility
Opiate Substitution Treatment
Opioid-Related Disorders -- drug therapy
Outcome Assessment (Health Care)
Community-Institutional Relations
Buprenorphine -- therapeutic use
Inservice Training
Insurance Coverage
Methadone -- therapeutic use
Naloxone -- therapeutic use
Naltrexone -- therapeutic use
Prescription Drug Diversion -- prevention & control
Humans
United States
United States. Department of Health and Human Services.

208. Medicare and Medicaid: CMS needs to fully align its antifraud efforts with the fraud risk framework : report to Congressional addressees

Publication:
Washington, DC : United States Government Accountability Office, December 2017
Subject(s):
Fraud -- prevention & control
Health Insurance Exchanges
Medicaid
Medicare
Risk Assessment
Risk Management
Fraud -- economics
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)
State Children's Health Insurance Program (U.S.)

209. Pulling together: administrative and budget consolidation of state long-term care services

Publication:
Washington, D.C. : AARP Public Policy Institute, c2006
Subject(s):
Budgets
Long-Term Care -- organization & administration
State Government
Government Agencies -- organization & administration
Medicaid -- economics
Medicare -- economics
Organizational Case Studies
Humans
Minnesota
New Mexico
Oregon
United States
Vermont
Washington
United States. Department of Health and Human Services.

210. Early changes in waivered clinicians and utilization of buprenorphine for opioid use disorder after implementation of the 2021 HHS Buprenorphine Practice Guidelines

Publication:
Washington, D.C. : U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, December 2, 2022
Subject(s):
Buprenorphine -- therapeutic use
Drug Prescriptions -- statistics & numerical data
Drug Utilization -- statistics & numerical data
Drug Utilization -- trends
Opioid-Related Disorders -- drug therapy
Practice Guidelines as Topic
Scope of Practice
United States
United States. Department of Health and Human Services.

211. Pathological complete response in neoadjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval

Publication:
[Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):
Breast Neoplasms
Clinical Trials as Topic
Neoadjuvant Therapy
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

212. 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.

213. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, July 2020
Subject(s):
Biological Products
Tissues
Cell- and Tissue-Based Therapy
Tissue Transplantation
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

214. Cancer clinical trial eligibility criteria: minimum age considerations for inclusion of pediatric patients : guidance for industry and IRBs

Publication:
Silver Spring, MD : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):
Clinical Trials as Topic
Eligibility Determination
Neoplasms
Pediatrics
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

216. Cancer clinical trial eligibility criteria: patients with organ dysfunction or prior or concurrent malignancies

Publication:
[Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):
Clinical Trials as Topic
Eligibility Determination
Heart Failure
Liver Failure
Neoplasms
Renal Insufficiency
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

217. Marketing status notifications under Section 506I of the Federal Food, Drug, and Cosmetic Act: content and format

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, August 2020
Subject(s):
Legislation, Drug
Legislation, Food
Marketing -- legislation & jurisprudence
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

218. Enforcement priorities for electronic nicotine delivery systems (ENDS) and other deemed products on the market without premarket authorization (revised)

Publication:
Silver Spring, MD : Center for Tobacco Products, April 2020
Subject(s):
Adolescent Behavior
Adolescent Health
Electronic Nicotine Delivery Systems
Vaping -- prevention & control
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

219. Temporary policy regarding accredited third-party certification program onsite observation and certificate duration requirements during the COVID-19 public health emergency

Publication:
[College Park, MD] : Center for Food Safety and Applied Nutrition, April 2020
Subject(s):
Accreditation -- methods
Certification -- methods
Food Safety
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

220. Temporary policy on repackaging or combining propofol drug products during the COVID-19 public health emergency

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, Office of Pharmaceutical Quality and Office of Compliance, April 2020
Subject(s):
Drug Packaging -- methods
Propofol -- supply & distribution
COVID-19
Drug Labeling
Pharmacies
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

221. 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, August 2020
Subject(s):
Blood Donors
Blood Transfusion
Creutzfeldt-Jakob Syndrome -- prevention & control
Creutzfeldt-Jakob Syndrome -- transmission
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

224. 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.

225. Temporary policy for compounding of certain drugs for hospitalized patients by outsourcing facilities during the COVID-19 public health emergency (revised)

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

226. Enforcement policy for clinical electronic thermometers 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):
Thermometers -- supply & distribution
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

227. 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.

228. Cancer clinical trial eligibility criteria: patients with HIV, hepatitis B Virus, or hepatitis C Virus Infections

Publication:
[Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):
Clinical Trials as Topic
Hepatitis B
Hepatitis C
HIV
Neoplasms
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

231. 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
Ethanol
Hand Sanitizers
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

232. Conventional Foley catheters--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):
Equipment Design
Equipment Safety
Urinary Catheterization
Urinary Catheters -- standards
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

233. 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.

235. 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.

238. Enforcement policy for infusion pumps and accessories 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):
Infusion Pumps
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

239. 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.

240. 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.

241. 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.

242. 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.

243. 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.

244. 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.

247. 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 therapy
Drugs, Investigational
Ethics Committees, Research
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

248. 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.

250. Patient-focused drug development: collecting comprehensive and representative input : guidance for industry, Food and Drug Administration staff, and other stakeholders

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2020
Subject(s):
Drug Development
Feedback
Sampling Studies
Patient Reported Outcome Measures
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.