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New Areas of ICH Harmonization

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The International Council for Harmonization Assembly approves the addition of three new topics for harmonization.

FDA Extends Neffy NDA Review

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FDA has extended by three months an ARS Pharmaceuticals NDA for neffy (intranasal epinephrine) for treating allergic reactions, in...

Surmodics Drug-Coated Balloon Approved

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FDA approves Surmodics SurVeil drug-coated balloon and its use in percutaneous transluminal angioplasty.

FDA Reports on State of Pharmaceutical Quality

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The CDER Office of Pharmaceutical Quality FY 2022 report on pharmaceutical quality shows a significant increase in drug site surve...

Legislation Introduced on Drug Supplies, Shortages

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Senators Gary Peters (D-MI) and Joni Ernst (R-IA) introduce bipartisan legislation to ensure the government is better prepared to ...

Pfizer NDA Approved for Prostate Cancer

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FDA approves a Pfizer NDA for Talzenna (talazoparib) with Astellas Xtandi (enzalutamide) for treating certain patients with gene-m...

Harvard Drug Recalls Drugs Due to Mislabeling

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The Harvard Drug Group recalls a single lot of dronabinol capsules (2.5 mg) and ziprasidone hydrochloride capsules (20 mg) after r...

Review Extended on GSKs Momelotinib

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FDA extends by three months its review of a GSK NDA for momelotinib, indicated for treating myelofibrosis patients with anemia.

Philips Safety Alert on Azurion/Allura Devices

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Philips issues an urgent field safety notice about its Azurion and Allura Xper systems installed with the FlexMove option, which c...

FDA Posts 483 of iRhythms CA Facility

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A just-posted, four-item Form FDA-483 sheds light on medical device reporting and other violations cited in a 2022 inspection of i...