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Revised BA/BE Sample Handling Guidance

[ Price : $8.95]

FDA issues a revised final and draft guidance on the handling and retention of BA and BE testing samples.

Bioresearch Monitoring Issues at New York Site

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FDA warns Dr. Bret Rutherford about violations in his work as a clinical study investigator at the New York State Psychiatric Inst...

Mesoblast Refiling BLA for Remestemcel-L

[ Price : $8.95]

Mesoblast says it will refile its BLA for remestemcel-L for treating pediatric steroid-refractory acute graft versus host disease ...

FDA Warns Against Topical OTC Analgesics

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FDA issues a warning to not use certain over-the-counter analgesic products that are marketed for topical use to relieve pain befo...

PARP Inhibitor Ovarian Cancer Indications Withdrawn

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Federal Register notice: FDA announces that it is withdrawing approval of the indications for treating adult patients with advance...

Quantitative Medicine Center of Excellence Created

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CDER creates a new Center of Excellence for Quantitative Medicine to advance therapeutic medical product development and inform re...

4 Information Collections Approved by OMB

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FDA posts a notification about four information collections that have been approved by OMB.

Medline Recalls Kits/Tray Over Sterility

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Medline Industries recalls certain kits, trays and packs in direct response to Nurse Assists 11/2023 recall of 0.9% sodium chlorid...

J&Js Opsynvi OKd for Pulmonary Hypertension

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FDA approves Johnson & Johnsons Opsynvi, a combination single tablet of macitentan and tadalafil for treating adults with pulmonar...

Regeneron Complete Response on Lymphoma BLA

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FDA sends Regeneron Pharmaceuticals two complete response letters on its BLA for odronextamab in relapsed/refractory follicular ly...