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8451. Laser products: conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 : (Laser Notice No. 56) : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, May 8, 2019
Subject(s):: Equipment Safety
Lasers -- classification
Lasers -- standards
Certification
Device Approval -- standards
Guideline Adherence
Product Labeling
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8452. Classification and requirements for laser illuminated projectors (LIPs): (Laser Notice No. 57) : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, May 8, 2019
Subject(s):: Equipment Safety
Lasers -- classification
Lasers -- standards
Device Approval
Lasers -- adverse effects
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8453. Preparation of food contact notifications for food contact substances in contact with infant formula and/or human milk

Publication:: College Park, MD : Center for Food Safety and Applied Nutrition, May 2019
Subject(s):: Food Contamination -- prevention & control
Food Safety
Infant Formula -- standards
Milk, Human -- chemistry
Carcinogenicity Tests
Infant
Infant, Newborn
Toxicity Tests
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8454. Recommendations for reducing the risk of transfusion-transmitted babesiosis

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, May 2019
Subject(s):: Babesiosis -- transmission
Blood Transfusion
Disease Transmission, Infectious -- prevention & control
Donor Selection -- standards
Babesiosis -- prevention & control
Blood -- microbiology
Surveys and Questionnaires
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8455. Determining whether to submit an ANDA or a 505(b)(2) application

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2019
Subject(s):: Drug Approval
Drugs, Investigational
Investigational New Drug Application
Drug Labeling
Therapeutic Equivalency
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

8456. Maximal usage trials for topically applied active ingredients being considered for inclusion in an over-the -counter monograph: study elements and considerations

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2019
Subject(s):: Administration, Topical
Drug Approval
Nonprescription Drugs
Absorption, Physiological
Clinical Trials as Topic
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8457. Oncology pharmaceuticals: reproductive toxicity testing and labeling recommendations

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2019
Subject(s):: Antineoplastic Agents -- adverse effects
Mutagenicity Tests -- standards
Neoplasms -- drug therapy
Reproduction -- drug effects
Teratogens
Toxicity Tests -- standards
Contraception
Drug-Related Side Effects and Adverse Reactions
Fertility
Geriatrics
Pediatrics
Postmenopause
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8458. Considerations in demonstrating interchangeability with a reference product

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2019
Subject(s):: Biosimilar Pharmaceuticals -- standards
Drug Substitution
Proteins -- therapeutic use
Biological Products
Clinical Trials as Topic
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8459. FDA deems certain tobacco products subject to FDA authority, sales and distribution restrictions, and health warning requirements for packages and advertisements: (revised)

Publication:: Silver Spring, MD : Food and Drug Administration, Center for Tobacco Products, March 2019
Subject(s):: Commerce -- legislation & jurisprudence
Product Labeling -- legislation & jurisprudence
Tobacco Products -- legislation & jurisprudence
Tobacco Products -- supply & distribution
Advertising -- legislation & jurisprudence
Tobacco Products -- adverse effects
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

8460. Extension of certain tobacco product compliance deadlines related to the final deeming rule: (revised)

Publication:: Silver Spring, MD : Food and Drug Administration, Center for Tobacco Products, March 2019
Subject(s):: Product Labeling -- legislation & jurisprudence
Tobacco Products -- legislation & jurisprudence
Guideline Adherence
Tobacco Products -- adverse effects
Tobacco Products -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

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