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Guidance on Blood Donor Questionnaires

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Federal Register Notice: FDA releases a guidance on implementing full-length donor history questionnaires and accompanying materia...

Comments Sought on Orphan Drug

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Federal Register Notice: FDA seeks comments on procedures for orphan drug sponsors to requests eligibility for the incentives.

FDA Clears Viasys Healthcare 510(k)

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FDA clears a Viasys Healthcare 510(k) for a new nasal continuous positive airway pressure option for use with its Avea neonatal ve...

FDA Clears Rheumatoid Arthritis Assay

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FDA clears a Phadia 510(k) for its EliA CCP, a fully automated assay for measuring cyclic citrullinated peptide antibodies in rheu...

AstraZeneca Dumps Stroke Drug After Disappointing Results

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AstraZeneca says it will no longer study its stroke drug NXY-059 after disappointing trial results showed the drug failed to meet ...

InterMune To Pay $36.9 Million for Illegal Marketing

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Federal officials say InterMune will pay $36.9 million to resolve criminal and civil actions arising from its illegal marketing of...

Drug Firms Have Sample Reporting System

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The PDMA Alliance launches an online reporting system to help companies comply with drug sample incident reporting requirements in...

FDA OKs Impaxs Generic Colestid

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FDA approves an Impax Laboratories ANDA for a generic version of Pfizers Colestid tablets.

Ontak Case Study Misleading

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DDMAC warns Ligand over a professional promotion for Ontak and Targretin.

Alcon Hit with Third Ad Violation in 18 Months

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DDMAC sends Alcon its third ad-violation letter in 18 months.