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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.