What's New: Drugs RSS Feed

  • Non-clinical Immunogenicity Assessment of Generic Peptide Products: Development, Validation, and Sampling  - 01/26/2021 - 01/26/2021

    Non-clinical Immunogenicity Assessment of Generic Peptide Products: Development, Validation, and Sampling - 01/26/2021 - 01/26/2021

    The FDA is hosting a workshop to communicate regulatory concerns and considerations with using non-clinical assays for comparative immunogenicity risk assessment. In addition, this workshop seeks...

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  • FDALabel:  Full-Text Search of Drug Labeling

    FDALabel: Full-Text Search of Drug Labeling

    FDALabel Database is a web-based application that allows users to perform customizable searches of a database containing over 100,000 drug labeling documents for FDA-approved drug products,...

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  • Recently Issued Guidance Documents

    Recently Issued Guidance Documents

    This page lists Recently Issued CBER and Cross-Center Guidance Documents.

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  • FDA-NRC Workshop Enhancing Development of Emerging Technologies: Radiopharmaceuticals and Radiological Devices - 10/14/2020 - 10/14/2020

    FDA-NRC Workshop Enhancing Development of Emerging Technologies: Radiopharmaceuticals and Radiological Devices - 10/14/2020 - 10/14/2020

    Virtual Meeting Workshop

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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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  • Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry

    Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry

    Clinical Pharmacology

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  • Newly Added Guidance Documents

    Newly Added Guidance Documents

    Guidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months.

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  • Coronavirus Treatment Acceleration Program (CTAP)

    Coronavirus Treatment Acceleration Program (CTAP)

    CTAP will use every available method to move new treatments to patients as quickly as possible, balancing patient needs for medicine while supporting trials to gather evidence and weighing the...

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  • Coronavirus Treatment Acceleration Program (CTAP) Frequently Asked Questions

    Coronavirus Treatment Acceleration Program (CTAP) Frequently Asked Questions

    Frequently Asked Questions about the Coronavirus Treatment Acceleration Program (CTAP)

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  • Canadian Chaga - 609097 - 08/06/2020

    Canadian Chaga - 609097 - 08/06/2020

    Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

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  • Over-the-Counter (OTC) Drug Monograph Process

    Over-the-Counter (OTC) Drug Monograph Process

    The Over-the-Counter (OTC) Drug Review was established to evaluate the safety and effectiveness of OTC drug products marketed in the United States before May 11, 1972.

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  • FDA updates on hand sanitizers consumers should not use

    FDA updates on hand sanitizers consumers should not use

    FDA Warns consumers and healthcare professionals of Hand Sanitizers contaminated with Methanol

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  • Over-The-Counter Monograph User Fee Program (OMUFA)

    Over-The-Counter Monograph User Fee Program (OMUFA)

    A user fee program for nonprescription (over-the-counter or OTC) monograph drugs would be a potential funding mechanism to supplement congressional non user-fee appropriations.

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  • UVT, INC. Issues Voluntary Nationwide Recall of SANIDERM ADVANCED HAND SANITIZER Due to the Potential Presence of Undeclared Methanol (Wood

    UVT, INC. Issues Voluntary Nationwide Recall of SANIDERM ADVANCED HAND SANITIZER Due to the Potential Presence of Undeclared Methanol (Wood

    UVT, INC. is voluntarily recalling 38,830 liters of SANIDERM ADVANCED HAND SANITIZER, packaged in 1-liter bottles to the consumer level. The products are being recalled due to the potential...

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  • Saniderm Products Voluntarily Issues Regional (Virginia, Maryland, New Jersey) Recall of 1 L Saniderm Advanced Hand Sanitizer bottles produc

    Saniderm Products Voluntarily Issues Regional (Virginia, Maryland, New Jersey) Recall of 1 L Saniderm Advanced Hand Sanitizer bottles produc

    Saniderm Products (Saniderm) is voluntarily recalling Saniderm Advanced Hand Sanitizer, packaged in 1-liter bottles to the consumer level. The products are being recalled due to the potential...

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  • FDA Voices on Medical Products

    FDA Voices on Medical Products

    FDA Voices on Medical Products

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  • FDA Voices

    FDA Voices

    Insights into the agency's work in the areas of medical products, food, tobacco, policy, consumer safety and enforcement.

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  • Health Fraud Scams

    Health Fraud Scams

    Learn how to spot health fraud and avoid it.

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  • FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma

    FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma

    Hematology / Oncology News Burst

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  • An Exciting New Chapter in OTC Drug History: OTC Monograph Reform in the CARES Act

    An Exciting New Chapter in OTC Drug History: OTC Monograph Reform in the CARES Act

    The CARES Act includes OTC monograph reform provisions granting the FDA transformative new authorities that will meaningfully advance our efforts to modernize the OTC monograph drug development...

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