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FDA Questions Ardelyx Tenapanor

[ Price : $8.95]

FDA medical reviewers ask the Cardiovascular and Renal Drugs Advisory Committee to consider whether the benefits of Ardelyx tenapa...

Workshop on Using Consensus Standards in Device Submissions

[ Price : $8.95]

FDA announces a 12/7 public workshop on Appropriate Use of Consensus Standards to obtain public input on using these in premarket ...

1 Observation on Athenex Pharma FDA-483

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FDA releases the form FDA-483 issued following an inspection at the Clarence, NY-based Athenex Pharma Solutions outsourcing facili...

Comments on Computer Software Assurance Guidance

[ Price : $8.95]

Three stakeholders recommend broadening the impact of an FDA draft guidance on computer software assurance.

AdvaMed Tells FDA to Scrap LASIK Labeling Guidance

[ Price : $8.95]

AdvaMed says FDA should withdraw its draft guidance on LASIK patient labeling recommendations because the group has numerous conce...

Roche Molecular Gets EUA for Monkeypox Test

[ Price : $8.95]

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

Warning Letter Top 10 GMP Deficiencies

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

Mendoza Debarred for 5 Years Over Drug Imports

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Federal Register notice: FDA issues an order debarring David Elias Mendoza for five years from importing or offering for import an...

FDA Clears Surgical Augmented Reality Software

[ Price : $8.95]

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

Protalix, Chiesi Resubmit Fabry Disease BLA

[ Price : $8.95]

Protalix BioTherapeutics and Chiesi Global Rare Diseases resubmit a BLA for PRX102 (pegunigalsidase alfa) for treating adult patie...