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FDA to Test Ad Price Incentives

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FDA plans to test the impact of price offers embedded in DTC print ads on consumer perception of product risks and benefits.

FDA Accepts for Review a Duramed BLA for Vaccine

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FDA accepts for review a Duramed Pharmaceuticals BLA for its Adenovirus Types 4 and 7 Live Oral Vaccine, a vaccine developed under...

Should FDA Require Pre-market ICD Trials?

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CDRH director Daniel Schultz responds to critics who say a new ICD lead should be subject to clinical trials before marketing by s...

FDA Issues Draft 510(k) Sterility Info Guidance

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FDA issues a draft guidance updating and clarifying procedures for reviewing 510(k) submissions for devices labeled as sterile.

Proposed Massachusetts Marketing Regs Out

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The Massachusetts Department of Public Health releases for comment proposed regulations implementing a marketing code of conduct f...

More Data Needed for Remoxy NDA

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FDA says Pain Therapeutics must provide more non-clinical data to support approval of its NDA for Remoxy.

New PhRMA Code Doesnt Go Far Enough: Critics

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Capitol Hill lawmakers and advocacy groups criticize PhRMAs revised marketing code on DTC ads, saying that it doesnt go far enough...

Guidance on Modifications to Devices

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Federal Register Notice: FDA releases a guidance on modifications to devices subject to PMA.

FDA Wants More Long-term Data on MS Drug

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FDA tells Impax Laboratories that it needs to collect additional longer-term controlled clinical data on the safety and efficacy o...

Boxed Warning for Bowel Cleansing Products

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FDA orders a boxed warning on labeling for two prescription bowel cleansing products due to risk of a type of kidney injury.