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FDA Draft Report on Standardizing REMS

[ Price : $8.95]

FDA releases a draft report entitled Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS) that describes ...

OMB OKs Collection of Info on National Stockpile

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Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on exceptions or alternativ...

FDA Proposes Iontophoresis Devices into Class 2

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Federal Register Proposed order: FDA proposes to reclassify iontophoresis devices intended for any other purposes into Class 2.

CDER Denies Petition Seeking Reformulated ADHD Drugs

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CDER denies a 2006 citizen petition from physician John C. Kulli that requested it issue a regulation requiring attention deficit ...

FDA Approves New Test for Detecting Yeast Pathogens

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FDA approves a de novo petition to allow the marketing of T2 Biosystems direct blood test for detecting five yeast pathogens that ...

FDA Breakthrough Designation for Eylea in Diabetic Retinopathy

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FDA grants Regeneron Pharmaceuticals a breakthrough therapy designation for Eylea injection for treating diabetic retinopathy in p...

OPDP Cites Cipher Pharma Over e-Pharm Emails

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CDERs Office of Prescription Drug Promotion objects to a Cipher Pharmaceuticals e-Pharm/alert email for Lipofen (fenofibrate capsu...

Bill to Free REMS-blocked Drug Samples for Generics

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A new House bill aims to close a loophole that is used by some brand drug makers to prevent potential generic drug firms from obta...

OIG Advisory on Drug Copayment Coupons

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A special advisory bulletin from HHS Office of Inspector General raises concerns on the measures used by pharmaceutical manufactur...

Orphan Status for Navidea Drug in Head, Neck Cancer

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FDA grants orphan drug status to Navidea Biopharmaceuticals for Lymphoseek Injection for sentinel lymph node detection in head and...