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Docs Visit Diabetes Drug Sites

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Primary care physicians visit several diabetes drug Web site more than sites for many other drugs.

AHF says HIV Ads Target Treatment Fears

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AIDS Healthcare Foundation says two GSK print ads strengthen patient fears about HIV treatments.

Kimberly-Clark Marketing Unapproved Devices: FDA

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CDRH says Kimberly-Clark Healthcare made significant changes to models of its sterilization wraps that require submission of new 5...

CGMP Problems at Sandoz Plant

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FDAs Atlanta District Office cites several significant CGMP violations found at Sandoz Wilson, NC, drug manufacturing facility.

Despite Rule, FDA Redacts Public Comments on LASIK

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FDA apparently violates its own regulations to redact names, affiliations and other information from 246 public comments it has po...

Drug Industry Reluctant to Move to PAT Controls

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CDER Division of Manufacturing and Product Quality director Rick Friedman tells a GMP conference that industry is reluctant to mov...

FDA Targeting Recall Root Causes in Research Project

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CDER examines the root causes of drug recalls to provide information to field investigators, reviewers and industry to help preven...

Zanosar in Short Supply

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FDA says Teva Parenteral Medicines Zanosar is in short supply due to manufacturing delays.

Chelseas Droxidopa Gets Fast Track

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FDA grants fast track designation and other review advantages for Chelseas Droxidopa for treating symptomatic neurogenic orthostat...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Cascadia Manufacturing, Cochlear Bone Anchored Solutions, Gaunitz Hair Sciences,...