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Data on Under-Represented Patients Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Postmarketing Approaches to Obtain Data on Under-Represente...

Guide on Biosimilar Supplement Classifications

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Classification Categories for Certain Supplements Under BsU...

Anjeso Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Baudax Bios Anjeso (meloxicam) solution, 30 mg/mL, was not withdrawn from sale due to...

PAS Classification Category Guidance

[ Price : $8.95]

FDA publishes a draft guidance with information on prior approval supplement classification categories A-F.

Comments Sought on Drug Supply Tracing Tech

[ Price : $8.95]

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

Info Collection on Radioactive Drug Committees

[ Price : $8.95]

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

Explain FDA Vaccine Approval Process: Study

[ Price : $8.95]

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

FDA Approves Janssens Talvey

[ Price : $8.95]

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

Underrepresented Population Data Guidance

[ Price : $8.95]

FDA publishes a draft guidance on obtaining postmarketing safety and effectiveness information on drugs in historically underrepre...

FDA Updates Regulatory Science Device Catalog

[ Price : $8.95]

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