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2811. 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.

2812. 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.

2813. 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.

2814. 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.

2815. 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.

2818. 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.

2819. 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.