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27801. General principles for evaluating the abuse deterrence of generic solid oral opioid drug products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):: Abuse-Deterrent Formulations -- standards
Analgesics, Opioid -- administration & dosage
Drugs, Generic
Investigational New Drug Application
Administration, Oral
Administration, Inhalation
Clinical Trials as Topic
Drug Evaluation, Preclinical
Injections
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

27802. Pediatric information for x-ray imaging device premarket notifications: guidance for industry and Food and Drug Administration staff

27803. Nucleic acid testing (NAT) for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV): testing, product disposition, and donor deferral and reentry

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, December 2017
Subject(s):: Blood Donors
Donor Selection -- standards
Hepacivirus
Hepatitis C -- blood
HIV Infections -- blood
HIV-1
RNA, Viral -- blood
Blood -- virology
Blood Transfusion
Disease Transmission, Infectious -- prevention & control
Nucleic Acid Amplification Techniques
Polymerase Chain Reaction
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

27804. FDA categorization of investigational device exemption (IDE) devices to assist the Centers for Medicare and Medicaid Services (CMS) with coverage decisions: guidance for sponsors, clinical investigators, industry, institutional review boards, and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, December 5, 2017
Subject(s):: Device Approval
Equipment and Supplies
Insurance Coverage
Medicare -- economics
Therapies, Investigational
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
Centers for Medicare & Medicaid Services (U.S.)

27805. Technical considerations for additive manufactured medical devices: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, December 5, 2017
Subject(s):: Computer-Aided Design -- standards
Device Approval
Manufactured Materials -- standards
Materials Testing -- standards
Printing, Three-Dimensional -- standards
Quality Control
Computer Security -- standards
Diagnostic Imaging
Models, Anatomic
Product Labeling -- standards
Reproducibility of Results
Software -- standards
Sterilization -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

27806. Use of serological tests to reduce the risk of transmission of Trypanosoma cruzi infection in blood and blood components

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, December 2017
Subject(s):: Blood Donors
Chagas Disease -- blood
Chagas Disease -- transmission
Disease Transmission, Infectious -- prevention & control
Donor Selection
Serologic Tests
Trypanosoma cruzi
Chagas Disease -- prevention & control
Risk Management
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

27807. Software as a medical device (SAMD): clinical evaluation : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, December 8, 2017
Subject(s):: Equipment and Supplies -- standards
Reproducibility of Results
Software -- standards
International Cooperation
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

27808. Product name placement, size, and prominence in promotional labeling and advertisements

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2017
Subject(s):: Advertising as Topic -- standards
Prescription Drugs -- standards
Product Labeling -- standards
Mass Media
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

27809. Systemic antibacterial and antifungal drugs: susceptibility test interpretive criteria labeling for NDAs and ANDAs

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2017
Subject(s):: Antibacterial Agents
Antifungal Agents
Drug Labeling -- standards
Investigational New Drug Application
Microbial Sensitivity Tests
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

27810. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2017
Subject(s):: Biological Availability
Drugs, Investigational -- pharmacokinetics
Investigational New Drug Application
Therapeutic Equivalency
Administration, Oral
Biopharmaceutics -- classification
Drugs, Investigational -- administration & dosage
Excipients
Permeability
Prodrugs
Solubility
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.