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FDA Deploying Staff to Puerto Rico to Help Manufacturers, Residents

[ Price : $8.95]

FDA deploys additional staff to Puerto Rico to work with pharmaceutical and device companies to prevent shortages of medically nec...

FDA/SOCRA Clinical Trial Requirements Conference

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Federal Register notice: FDA announces an educational conference co-sponsored with the Society of Clinical Research Associates on ...

Comments Sought on Form 3674 Certifications

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Federal Register notice: FDA seeks comments on a information collection extension for its Certification To Accompany Drug, Biologi...

FDA Panel to Review Pfizer Staph Vaccine Development Plan

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Federal Register notice: FDA announces an 11/7 Vaccines and Related Biological Products Advisory Committee meeting to review a cli...

Researchers Urge Better FDA Monitoring of Post-approval Studies

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Researchers from the Dartmouth Institute for Health Policy and Clinical Practice say FDA should be doing more to ensure pharmaceut...

FDA Accelerated OK for Mercks Keytruda in Gastric Cancer

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FDA grants accelerated approval to Mercks Keytruda (pembrolizumab) for treating certain patients with recurrent locally advanced o...

FDA Approves MRI-friendly Labeling for Abbott ICD and Leads

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FDA has approved magnetic resonance-conditional labeling for Abbotts Ellipse implantable cardioverter defibrillator and associated...

FDA Complete Response on Janssen Arthritis BLA

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FDA issues Janssen Biotech a complete response letter on a BLA for sirukumab and its use in treating moderately to severely active...

Draft Guide for Biosimilar Analytical Similarity Evaluations

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Federal Register notice: FDA makes available a draft guidance entitled Statistical Approaches to Evaluate Analytical Similarity.

Aegerion Pharma Pleading Guilty to Violating REMS

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Aegerion Pharmaceuticals agrees to plead guilty in the Massachusetts federal court to two misdemeanor misbranding charges involvin...