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FDA Wont Cut Corners Regulating New Media: Woodcock

[ Price : $8.95]

CDER director Janet Woodcock tells an FDLI conference that despite the complexity of the new media environment FDA intends to vigo...

Drug, Biologics Centers Boost Ad Enforcement

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Increased enforcement actions against violative advertising and promotional materials are reported to an FDLI conference by two of...

Pfizer Funds Diabetes Survey, Education Effort

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Pfizer funds a study and educational campaign urging diabetic peripheral neuropathy sufferers to talk with their healthcare provid...

End-of-Phase 2A Meeting Guidance Out

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FDA issues a guidance to help IND sponsors participate effectively in end-of-Phase 2A meetings with the agency.

FDA Assumes NCE Status for Pancreatic Enzyme Products

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Attorney Kurt Karst says FDA has decided to apply its presumption in favor of NCE status for all pancreatic enzyme products.

Guidance on Therapeutic Cancer Vaccines

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Federal Register Notice: FDA releases a draft guidance on clinical considerations for therapeutic cancer vaccines.

ICH Prep Meeting Slated

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Federal Register Notice: FDA plans a public meeting 10/14 to prepare for the upcoming ICH meetings in St. Louis MO.

FDA Reviewing BSD Medical HDE on Cancer System

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BSD Medical says FDA is continuing its review of a humanitarian device exemption (HDE) submission for the BSD-2000 Hyperthermia Sy...

Hatch and Waxman Spar Over Health Issues at GPhA

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Orrin Hatch and Henry Waxman, co-sponsors of the 1984 legislation that created the modern generic pharmaceutical industry, spar ov...

The Troubles that Outsourced Clinical Trials Can Cause

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CDRH bioresearch monitoring director Michael Macarelli describes the dire consequences that can result from outsourcing clinical t...