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Boston Therapeutics IND for Type 2 Diabetes Therapy

[ Price : $8.95]

FDA accepts a Boston Therapeutics IND for BTI-320 for Type 2 diabetes and weight management.

FDA Grants BioMarin Orphan Drug for Sanfilippo Syndrome

[ Price : $8.95]

FDA grants orphan drug designation to BioMarin Pharmaceutical for BMN 250 to treat Sanfilippo Syndrome Type B or Mucopolysaccharid...

Covidien Recalls Puritan Bennett Ventilator

[ Price : $8.95]

Covidien recalls its Puritan Bennett 980 Ventilator systems due to a blacklight inverter defect where a capacitor component can fa...

Comments Sought on Public Hearing Procedures

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Federal Register Notice: FDA seeks comments on reporting requirements in FDA regulations on administrative practices for the forma...

Guidance on Patient Counseling Labeling Info

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Federal Register Notice: FDA releases a guidance: Patient Counseling Information Section of Labeling for Human Prescription Drug a...

Guidance on E-Standards for Veterinary Data Transfers

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Federal Register Notice: FDA releases a guidance: Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Tra...

Device Panel Meeting Postponed

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Federal Register Notice: FDA postpones a meeting of the Orthopedic and Rehabilitation Devices Panel scheduled to discuss a Vertifl...

Investigational Ebola Therapy Given Orphan Status

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FDA grants an orphan drug designation to ARCA Biopharma for rNAPc2 as a potential treatment of viral hemorrhagic fever post-exposu...

Public Meeting on Chagas Disease

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Federal Register Notice: FDA plans a public meeting 4/28/18 on patient-focused drug development for Chagas disease.

Panel to Discuss Sandoz Biosimilar

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Federal Register Notice: FDAs Oncologic Drugs Advisory Committee will meet 1/7/15 to discuss a Sandoz BLA for a proposed biosimila...