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Comments Sought on Tobacco Product Studies

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on consumer studies on perceptions of modified risk tobacco products.

CDER Releases SDTM Validation Rules

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Federal Register Notice: CDER is making available: Validation Rules for Study Data Tabulation Model (SDTM) Formatted Studies.

Guidance on Vaginal Microbicides for HIV

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Federal Register Notice: FDA is releasing a guidance: Vaginal Microbicides: Development for the Prevention of HIV Infection.

FDA Seeks Drug Risk/Benefit Perception Measures

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FDA proposes drug advertising research to give it a pool of measurement tools to evaluate consumer perceptions of risk and benefit...

Gilead Buys Priority Review Voucher for $125 Million

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Knight Therapeutics sells to Gilead Sciences for $125 million its Neglected Tropical Disease Priority Review Voucher that was gran...

FDA Grants Merrimack Pharma Fast Track Status for MM-398

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FDA grants Merrimack Pharmaceuticals a fast track designation for MM-398 (nanoliposomal irinotecan injection) for treating patient...

Chemistry Question-based Review MAPP

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CDERs Office of Pharmaceutical Science issues a MAPP on using a question-based review template.

Look at FDA Role in Drug Competition: Report

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A Matrix Global Advisors report says more attention should be paid to the ways in which FDA helps and hurts drug price competition...

New Requirements for Info on ClinicalTrials.gov

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The National Institutes of Health proposes new rules on registration and summary results information from some clinical trials for...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Eastern Pharmacy, Dr. Benedict Schue-Schie Liao, MKL Diagnostics, Wells Pharmacy...