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2-Day FDA Science Forum in May

[ Price : $8.95]

Federal Register notice: FDA announces a 5/26-27 workshop entitled FDA Science Forum 2021.

Technical Corrections for Drug Import Entries

[ Price : $8.95]

Federal Register notice: FDA amends its electronic import entries regulation to correct the statutory citation in the sections of ...

CDRH Medical Device Development Tools Help Developers: Shuren

[ Price : $8.95]

CDRH director Jeffrey Shuren describes the Centers Medical Device Development Tools program and Catalog of Regulatory Science Tool...

Advisory Committee Aducanumab Deliberations Explained

[ Price : $8.95]

Three university experts say their advisory committee experience with Biogens aducanumab shows the value in randomized clinical tr...

Higher Risk of Arrhythmias in Some Patients on Lamictal: FDA

[ Price : $8.95]

FDA says studies found an increased risk of heart arrhythmias in patients with heart disease who take GlaxoSmithKlines Lamictal or...

FDA Acellular Dermal Matrix Caution

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An FDA safety communication says there is a higher risk of complications in breast reconstruction using two specific brands of ace...

FDA Approves New Vyxeos Indication

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FDA approves an expanded indication for Jazz Vyxeos to include pediatric patients aged one and older.

Evive Bio BLA for Neutropenia Therapy

[ Price : $8.95]

Evive Biotech submits a BLA for Ryzneuta, indicated for treating chemotherapy-induced neutropenia.

LASIK Complaint on Violative Ads Seeks Woodcock Action

[ Price : $8.95]

The leader of a Facebook group with 7,400 members harmed by LASIK eye correction procedures urges FDA acting commissioner Janet Wo...

Latest FDA Warning Letter

[ Price : $8.95]

FDA releases its latest batch of Warning Letters that includes one medical product company PYRLess Group.