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80% of Docs Want DTC Ban for New Drugs

[ Price : $8.95]

Four-fifths of doctors surveyed by MedPanel say they favor an enforced moratorium on DTC ads for newly-approved drugs.

Orapred Web Site Doesnt Have Risk Info

[ Price : $8.95]

A DDMAC Warning Letter says a BioMarin Web site for Orapred minimizes risk, broadens the indication, and makes unsubstantiated com...

Solvay/Wyeth NDA for Schizophrenia Drug

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Solvay Pharmaceuticals and Wyeth Pharmaceuticals submit an NDA for bifeprunox, an atypical antipsychotic indicated for treating sc...

McNabb, Parents in Novartis Diabetes Effort

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Novartis enlists the help of Eagles quarterback Donovan McNabb and his parents in a diabetes education effort.

Guidance on Investigating OOS Results

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Federal Register Notice: FDA releases a guidance on investigating out-of-specification test results for pharmaceutical production.

Grassley Questions Artificial Blood Trial Ethics

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Sen. Chuck Grassley wants an HHS ethics advisory committee to look into whether informed consent waivers would include emergency r...

PharmDaily Launches Consumer Health Web Site

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PharmDaily.com launches a new consumer health Web site that also is open to drug company advertising,

Public Citizen Says Mentor Withheld Data

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Public Citizen calls for an FDA criminal investigation into a whistleblowers claim that Mentor withheld important breast implant s...

Nominations Sought for Device Panels

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Federal Register Notice: FDA requests nominations for voting members to serve on several device advisory panels and the Mammograph...

Review Period Corrected for Boniva

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Federal Register Notice: FDA corrects the regulatory review period for Roche/GlaxoSmithKlines Boniva for patent extension as 3,122...