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FDA, Austen BioInnovation Sign MOU on Biomaterials

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FDA and Austen BioInnovation Institute sign a Memorandum of Understanding to collaborate on the safe and effective use of biomater...

FDA Needs More Authority on Drug Shortages: GAO

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GAO reports that FDA needs more authority to effectively handle drug shortages, and HHS responds for the agency that it supports t...

FDA Clears Critical Diagnostics ST2 Assay

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FDA clears a Critical Diagnostics 510(k) for the Presage ST2 Assay for use as an aid in assessing the prognosis of patients diagno...

CMS Delays Gift Recording Requirement

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CMS delays the deadline for drug, medical device, and biologics manufacturers to report payments of more than $10 they make to doc...

Senators Introduce Medical Device Patient Safety Act

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U.S. senators Chuck Grassley (R-IA), Richard Blumenthal (D-CT) and Herb Kohl (D-WI) introduce the Medical Device Patient Safety Ac...

ProstaScint Fact Sheet Misleading: OPDP

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CDERs Office of Prescription Drug Promotion says an EUSA ProstaScint fact sheet fails to provide important information, overstates...

FDA Not Requiring REMS for Cushings Drug

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FDA tells Corcept Therapeutics that it will not require a Risk Evaluation and Mitigation Strategy program as part of its NDA submi...

Salix Files NDA for HIV Diarrhea Drug

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Salix Pharmaceuticals submits an NDA to FDA for crofelemer, indicated for treating HIV-associated diarrhea.

FDA OKs Dako Breast Cancer Test Kit

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FDA approves Dakos HER2 CISH pharmDx Kit as an aid in assessing breast cancer patients for whom Herceptin is being considered.

Sebelius Action Shows HHS-FDA Relations to be Opaque

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FDA Webview editor Jim Dickinson reviews FDAs opaque relationships with HHS as shown in the aftermath of the Sebelius Plan B decis...