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6271. Compliance policy for the quantity of bioavailability and bioequivalence samples retained under 21 CFR 320.38(c)

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, August 2020
Subject(s):: Biological Availability
Therapeutic Equivalency
Biopharmaceutics
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6272. 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.

6273. Limited population pathway for antibacterial and antifungal drugs

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

6274. Alternative procedures for blood and blood components during the COVID-19 public health emergency

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, April 2020
Subject(s):: Blood Donors
Blood Transfusion
Plasma
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6275. 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.

6276. 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.

6277. 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.

6278. 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.

6279. 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.

6280. 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.

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