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FDA Grants Immunovaccine Fast Track for Cancer Vaccine

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FDA grants Immunovaccine a fast track designation for its lead cancer vaccine candidate, DPX-Survivac, for maintenance therapy in ...

House Omnibus Spending Bill Gives FDA a $37 Million Boost

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The House Appropriations Committee unveils a fiscal year 2015 Omnibus Appropriations bill that would fund FDA at $2.589 billion, a...

FDA Grants IDE Conditional OK for Scleroderma Trial

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FDA has granted conditional approval to Cytori Therapeutics for an Investigational Device Exemption to evaluate the Cytori Cell Th...

FDA Approves Expanded Use of Mercks Gardasil 9

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FDA approves a BLA supplement for Mercks Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) for preventing certain di...

Drug Makers Explore New Digital Marketing Ideas

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Bloomberg News says that some drug companies are experimenting with a digital marketing technique that allows it to identify group...

Bill Would Change FDA Expanded Access Program

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Rep. Michael McCaul introduces legislation to reform FDAs compassionate use policy.

Alere Corrects Testing System for Monitoring Warfarin Therapy

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Alere Inc. begins a voluntary correction to inform U.S. users of the Alere INRatio and INRatio 2 PT/INR Monitor system about certa...

FDA Clears CenterVue 510(k) for Confocal Scanner

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FDA clears a CenterVue 510(k) for its Eidon color confocal scanner, an automated retinal imaging system that combines confocal sca...

Critically Examine FDA Engagement Processes: MS Society

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Stakeholders urge FDA to continue to look for better ways to engage patients in providing information to the agency for use in pro...

FDA Guidance on Patient Counseling Info Section in Drug Labels

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FDA posts a final guidance on Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Produc...