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Comments on Computer Software Assurance Guidance

Three stakeholders recommend broadening the impact of an FDA draft guidance on computer software assurance.

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Medical Devices

AdvaMed Tells FDA to Scrap LASIK Labeling Guidance

AdvaMed says FDA should withdraw its draft guidance on LASIK patient labeling recommendations because the group has numerous concerns about the docume...

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Medical Devices

Roche Molecular Gets EUA for Monkeypox Test

FDA issues Roche Molecular Systems an emergency use authorization for its cobas MPXV monkeypox test.

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Human Drugs

Warning Letter Top 10 GMP Deficiencies

ECA Academy lists the top 10 GMP observations from 42 Warning Letters issued in FY 2022.

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Federal Register

Mendoza Debarred for 5 Years Over Drug Imports

Federal Register notice: FDA issues an order debarring David Elias Mendoza for five years from importing or offering for import any drug into the U.S.

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Medical Devices

FDA Clears Surgical Augmented Reality Software

FDA clears a Xironetic 510(k) for its IntraOpVSP augmented reality (AR) visualization software for use in complex surgeries.

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Biologics

Protalix, Chiesi Resubmit Fabry Disease BLA

Protalix BioTherapeutics and Chiesi Global Rare Diseases resubmit a BLA for PRX102 (pegunigalsidase alfa) for treating adult patients with Fabry disea...

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Human Drugs

Roche Alzheimers Drug Misses in 2 Phase 3 Studies

Roche says results from two Phase 3 studies evaluating Alzheimers therapy gantenerumab were not statistically significant in slowing clinical decline....

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Federal Register

Guide on Device Definition in Regulatory Documents

Federal Register notice: FDA makes available a final guidance entitled Referencing the Definition of a Device in the Federal Food, Drug, and Cosmetic ...

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Federal Register

Regulatory Review Period for Mercks Prevymis

Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for Mercks Prevymis (letermovir) intravenous s...