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Federal Register

Data on Under-Represented Patients Guide

Federal Register notice: FDA makes available a draft guidance entitled Postmarketing Approaches to Obtain Data on Under-Represented Populations in Cli...

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Federal Register

Guide on Biosimilar Supplement Classifications

Federal Register notice: FDA makes available a draft guidance entitled Classification Categories for Certain Supplements Under BsUFA III.

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Federal Register

Anjeso Not Withdrawn Due to Safety/Efficacy

Federal Register notice: FDA determines that Baudax Bios Anjeso (meloxicam) solution, 30 mg/mL, was not withdrawn from sale due to safety or effective...

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Human Drugs

PAS Classification Category Guidance

FDA publishes a draft guidance with information on prior approval supplement classification categories A-F.

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Federal Register

Comments Sought on Drug Supply Tracing Tech

Federal Register notice: FDA seeks stakeholder comments on a Drug Supply Chain Security Act-mandated technology and software assessment that examines ...

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Federal Register

Info Collection on Radioactive Drug Committees

Federal Register notice: FDA sends to OMB an information collection extension entitled Radioactive Drug Research Committees.

Biologics

Explain FDA Vaccine Approval Process: Study

The Annenberg Public Policy Center recommends steps to reduce misinformation about the RSV vaccine and promote its use by pregnant women when one is a...

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Human Drugs

FDA Approves Janssens Talvey

FDA gives accelerated approval to Janssens Talvey to treat some adult multiple myeloma patients.

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Human Drugs

Underrepresented Population Data Guidance

FDA publishes a draft guidance on obtaining postmarketing safety and effectiveness information on drugs in historically underrepresented patient popul...

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Medical Devices

FDA Updates Regulatory Science Device Catalog

FDA adds four new and updates nine existing tools in its medical device regulatory science tools catalog.