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Guidance on Modified Risk Tobacco Products

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance on a preliminary timetable for FDAs review of applications for modified ris...

Panel to Discuss Forest sNDA for Chronic Heart Failure

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Federal Register Notice: FDAs Cardiovascular and Renal Drugs Advisory Committee will meet 1/11/10 to discuss a Forest Labs sNDA fo...

Tobacco Ingredients Guidance Out

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Federal Register Notice: FDA releases a guidance on the listing of ingredients in tobacco products.

Online Sample Promotions Downplay Risk Info: Study

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Researchers say that the number of drug company Web sites offering vouchers or coupons for free samples or discounted prescription...

FDA Orphan Status for BioMarin Drug

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FDA grants BioMarin Pharmaceutical an orphan drug designation for 3,4-diaminopyridine (3,4-DAP) amifampridine phosphate for treati...

FDA Refuse to File on EMD Serono NDA

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FDA issues EMD Serono a refuse-to-file letter on an NDA for cladribine tablets, indicated for treating relapsing forms of multiple...

Transcept and FDA Agree to Meet on Rejected Insomnia Drug

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Transcept Pharmaceuticals and FDA agree to meet 1/20/09 to discuss a Complete Response Letter on an NDA for Intermezzo (zolpidem t...

Consumers Dont Pay Attention to Risk Info: Study

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ORC Guideline says its latest research shows that many consumers dont pay attention to mandated risk information in TV and print d...

Woodcock Describes Pain Management Difficult Balance

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CDER director Janet Woodcock says that FDA is working with doctors, pharmacists, and others to strike a balance between access to ...

Patient Advocates Criticize Drug Company Data Mining

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The Chicago Tribune says that patient advocates and some doctors complain about prescription data mining practices.