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Pfizer Plans BLA for RSV Vaccine

[ Price : $8.95]

Pfizer plans a year-end BLA for its investigational bivalent respiratory syncytial virus vaccine after stopping enrollment in a Ph...

CDRH Testing Communications Info Collection

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection entitled Testing Communications by FDAs Center for Device...

Measuring Growth/Pubertal Development Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Measuring Growth and Evaluating Pubertal Development in Ped...

Guide on Cell/Tissue-based Products

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Regulation of Human Cells, Tissues, and Cellular and Tissue...

ICH Guide Aims to Reduce Rat Carcinogenic Studies: FDA

[ Price : $8.95]

FDA releases a guidance, S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals; International Council for Harmoni...

FDA Revises EUAs for Covid Serial Testing

[ Price : $8.95]

FDA revises the authorized uses and is requiring updates to product labeling regarding repeat (serial) testing for all currently a...

Special Protocol Assessment Information Collection

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Special Protocol Assessment.

Info Collection on BLA Procedures

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Biologics License Applications Procedu...

Measuring Growth and Evaluating Pubertal Development Guide

[ Price : $8.95]

FDA posts a draft guidance on recommendations for measuring and recording growth, and evaluating pubertal development for evaluati...

Special Protocol Assessment Information Collection

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Special Protocol Assessment.