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PhRMA Supports Streamlined GMPs for Combo Products

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Pharmaceutical Research and Manufacturers of America says it supports FDAs efforts to identify alternative or streamlined mechanis...

Workshop on Patient Experiences in Clinical Trials

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FDA hosts a 10/15-16 public workshop to convene a discussion on methodological approaches that may be used to develop and identify...

DTC Drug Pricing Amendment Shot Down on Hill

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House Republicans derail a Trump-supported legislative measure that would have required drug companies to include prices in their ...

Workshop on Blood Pathogen Reduction Technologies

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Federal Register notice: FDA announces an 11/28 public workshop entitled Pathogen Reduction Technologies for Blood Safety.

Guide on Consensus Standards Recognition/Withdrawal

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Federal Register notice: FDA makes available a draft guidance entitled Recognition and Withdrawal of Voluntary Consensus Standards...

Draft Guide on 510(k) Third-Party Review Program

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Federal Register notice: FDA makes available a draft guidance entitled 510(k) Third-Party Review Program.

Biotronik Device for Coronary Artery Perforations OKd

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FDA approves a Biotronik humanitarian device exemption for its PK Papyrus Covered Coronary Stent System which is intended to treat...

Sun Pharma Glaucoma Drug Approved

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FDA approves a Sun Pharmaceutical Industries NDA for Xelpros (latanoprost ophthalmic emulsion) 0.005% for reducing elevated intrao...

FDA Posts ANDA Bioequivalence Study Guides

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Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that recommend bioequiv...

PMRS Sues FDA Over Hearing on Rejected NDA

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Pharmaceutical Manufacturing Research Services files (XXX SPACE XXX)a lawsuit against FDA in eastern PA federal court seeking an o...