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Public Citizen Bashes Drug Compounding Bill

[ Price : $8.95]

Public Citizen says a Senate/House proposed compromise on a drug compounding bill would threaten patient safety by allowing outsou...

FDA Approves New Dosing Option for Hizentra

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FDA approves a new CSL Behring administration option for Hizentra (immune globulin subcutaneous human), 20% liquid to include dos...

CDRH Planning IDE Risk-Benefit Guidance

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CDRH Office of Device Evaluation regulations & guidance associate director Ashley Boam says the Center is developing a risk-benefi...

Glaxo Submits New Research on Inhalation Products

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GlaxoSmithKline says new research challenges FDAs proposed weight of the evidence approach to determining therapeutic equivalence ...

Integra Resolves NJ Manufacturing Issues Cited by FDA

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FDA tells Integra LifeSciences that it has addressed GMP violations cited in a 2011 Warning Letter relating to its Plainsboro, NJ ...

Court Dismisses Medtronic Sprint Lead Case

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A Nevada federal court agrees with Medtronic and dismisses as preempted by federal law a suit against the company alleging injurie...

FDA Awards NIMS Data Submission Contract

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FDA awards a contract to PointCross Life Sciences for NIMS software development and life cycle management.

FDA Finds Deficiencies in Amag Feraheme sNDA

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FDA identifies deficiencies in an Amag Feraheme sNDA and delays a decision until 10/21.

FDA Grants 2 Orphan Drug Designations for Bayers Riociguat

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FDA approves two orphan drug designations for Bayers riociguat.

Shuren: Well Meet or Exceed New User Fee Goals

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CDRH director Jeff Shuren says the Center is currently on track to meet or exceed new user fee goals negotiated under the FDA Safe...