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Virtus Pharma Recalls 7 Lots of Hyoscyamine Sulfate

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Virtus Pharmaceuticals recalls seven batches of hyoscyamine sulfate (0.125mg) due to both superpotent and subpotent test results.

AATD Patients Want Better Treatment Options

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Alpha-1 Antitrypsin Deficiency patients tell FDA of their daily struggles and desires for improved treatment.

Varian Gains Clearance for Nexus DR Imaging System

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Varian Medical Systems receives 510(k) clearance to market the Nexus DR, a high resolution imaging system for X-ray imaging using ...

Guidance on Total Kidney Volume Biomarker

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FDA releases a guidance on Qualification of Biomarker Total Kidney Volume (TKV) in Studies for Treatment of Autosomal Dominant Pol...

Psych Drug Ads Promote Prescribing: Study

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Brown University researchers say that limited study findings indicate that DTC ads for psychiatric medicines can lead to patient r...

Duchenne Drug Reviewer Farkas Leaves FDA for Parexel

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To Wall Street's relief, CDER Division of Neurology Products clinical team leader Ronald Farkas leaves FDA to join clinical resear...

FDA Cancels Dynavax Vaccine Committee Meeting

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Federal Register Notice: FDA cancels an 11/16-planned meeting of the Vaccines and Related Biological Products Advisory Committee t...

Withdrawal of NADA for Three-way Type A Medicated Drug

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Federal Register Notice: FDA withdraws approval of parts of a new animal drug application (NADA) for a three-way, fixed-ratio, com...

GAO Report Finds Generic Drug Prices Decreased Over 5 Years

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A new Government Accountability Office report finds that generic drug prices fell 59% from the first quarter of 2010 through the s...

OCI Internal Grand Jury E-mails Questioned: Reuters

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Attorneys interviewed by Reuters disagree about whether the FDA Office of Criminal Investigations is violating federal rules of cr...