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Human Drugs

Dont Approve Some Tc-99m NDAs: Petition

A citizen petition asks FDA not to approve any Technetium-99m product produced through neutron capture in a conventional generator.

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Human Drugs

CGMP Violations at Lupin Limited

FDA warns Indias Lupin Limited about CGMP deviations in the production of active pharmaceutical ingredients.

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Human Drugs

Use of Expedited Drug Review Programs Increasing

FDA researchers say industry use of the accelerated approval, breakthrough therapy, fast track, and priority review programs has increased since 2008 ...

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Human Drugs

FDA Defers Action on Amicus BLA

FDA says it is deferring action on an Amicus BLA for cipaglucosidase alfa as part of a treatment for Pompe disease until the agency can conduct a manu...

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Human Drugs

Pfizer Plans BLA for RSV Vaccine

Pfizer plans a year-end BLA for its investigational bivalent respiratory syncytial virus vaccine after stopping enrollment in a Phase 3 study that it ...

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Federal Register

CDRH Testing Communications Info Collection

Federal Register notice: FDA seeks comments on an information collection entitled Testing Communications by FDAs Center for Devices and Radiological H...

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Federal Register

Measuring Growth/Pubertal Development Guide

Federal Register notice: FDA makes available a draft guidance entitled Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Tria...

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Federal Register

Guide on Cell/Tissue-based Products

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

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Human Drugs

ICH Guide Aims to Reduce Rat Carcinogenic Studies: FDA

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

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Medical Devices

FDA Revises EUAs for Covid Serial Testing

FDA revises the authorized uses and is requiring updates to product labeling regarding repeat (serial) testing for all currently authorized Covid-19 a...