What's New: Drugs RSS Feed

  • REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary Guidance for Industry

    REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary Guidance for Industry

    This guidance is intended to clarify how the Food and Drug Administration (FDA or Agency) applies the factors set forth in section 505-1 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21...

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  • The Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification

    The Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification

    This document is a guide for implementing the standard adopted by the ICH for electronic transmission of Individual Case Safety Reports (ICSRs) according to the ICH E2B(R3) message standard.

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  • Drug Master Files: Guidelines

    Drug Master Files: Guidelines

    A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in...

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  • Immunotoxicology Evaluation of Investigational New Drugs

    Immunotoxicology Evaluation of Investigational New Drugs

    This guidance makes recommendations to sponsors of investigational new drugs (INDs) on (1) the parameters that should be routinely assessed in toxicology studies to determine effects of a drug on...

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  • Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products Guidance for Industry

    Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products Guidance for Industry

    This guidance has been developed to address the lack of clarity with respect to what chemistry, 17 manufacturing, and controls (CMC) information in a marketing application constitutes an 18...

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  • Clinical Drug Interaction Studies — Study Design, Data Analysis, and Clinical Implications Guidance for Industry

    Clinical Drug Interaction Studies — Study Design, Data Analysis, and Clinical Implications Guidance for Industry

    This guidance helps sponsors of investigational new drug applications and applicants of new drug 17 applications evaluate drug-drug interactions (DDIs) during drug development and communicate 18...

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  • FDA Regional Implementation Specifications for ICH E2B(R3) Implementation

    FDA Regional Implementation Specifications for ICH E2B(R3) Implementation

    This technical specifications document is to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation...

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  • Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product Guidance for Industry

    Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product Guidance for Industry

    Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product Guidance for Industry

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  • E2B(R3) The Electronic Transmission of Individual Case Safety Reports Implementation Guide —Appendix to the Implementation Guide — Backwards

    E2B(R3) The Electronic Transmission of Individual Case Safety Reports Implementation Guide —Appendix to the Implementation Guide — Backwards

    This document is an appendix to the Implementation Guide (IG) for the ‘International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)...

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  • E2B(R3) The Electronic Transmission of Individual Case Safety Reports Implementation Guide —Appendix to the Implementation Guide — Backwards

    E2B(R3) The Electronic Transmission of Individual Case Safety Reports Implementation Guide —Appendix to the Implementation Guide — Backwards

    This document is an appendix to the Implementation Guide (IG) for the ‘International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)...

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  • Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical

    Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical

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  • For Women: The FDA Gives Tips to Prevent Heart Disease

    For Women: The FDA Gives Tips to Prevent Heart Disease

    More women die from heart disease than from any other cause. But women can take action to decrease their risk. The FDA offers many resources to help educate women of all ages about the safe use of...

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  • When to Give Kids Medicine for Coughs and Colds

    When to Give Kids Medicine for Coughs and Colds

    Sometimes a cold is just a cold. What can worried parents do when their babies and young children have a cold or cough? The FDA has some advice and tips.

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  • WANTED: Consumers to Report Problems

    WANTED: Consumers to Report Problems

    Had an issue with a medicine, medical device, or food product and did not know who to notify? FDA's MedWatch is here to help.

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  • Some Medications and Driving Don't Mix

    Some Medications and Driving Don't Mix

    Some prescription and over-the-counter (OTC) medicines can cause reactions that may make it unsafe to drive

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  • Good Laboratory Practice Regulations Management Briefings, Post Conference Report, Aug 1979

    Good Laboratory Practice Regulations Management Briefings, Post Conference Report, Aug 1979

    Guidance for Industry, Good Laboratory Practice Regulations Management Briefings, Post Conference Report, Aug 1979

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  • About HIV and the Center for Drug Evaluation and Research's role

    About HIV and the Center for Drug Evaluation and Research's role

    Learn what HIV is and how CDER is working to prevent and treat HIV infections

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  • Consumer Updates

    Consumer Updates

    Get timely, reliable, health and safety information about food, drugs, medical devices, vaccines, pet food, pet medicine and more.

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  • Safely Soothing Teething Pain and Sensory Needs in Babies and Older Children

    Safely Soothing Teething Pain and Sensory Needs in Babies and Older Children

    Soothing children's gums with prescription or over-the-counter (OTC) medications, homeopathic remedies or teething jewelry can be dangerous. Consider these safer alternatives.

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  • What's New Related to Drugs

    What's New Related to Drugs

    Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.

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