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PDUFA V Talks the Time to Scale Back User Fees

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Steven Grossman writes in an FDA Matters column that it would be good to start to scale back CDER reliance on user fees by increas...

Changes in Epogen Professional Labeling Sought

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The Medial Technology and Practice Patterns Institute says that FDA should order changes to Epogen labeling to specify a safer tar...

Attorneys Share Best Practices for Off-label Communication

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Morgan, Lewis attorneys suggest ways in which drug and device companies can best communicate off-label information to healthcare p...

Guidance on End-of-Phase 2A Meetings

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Federal Register Notice: FDA releases a guidance on end-of-Phase 2A meetings for investigational new drug sponsors.

FDA OKs Abbott Automated HIV-1/HIV-2 Screening Test

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FDA approves Abbotts Prism HIV O Plus assay, a fully automated blood screening test for HIV-1/HIV-2.

Does FDA Have Authority for Company Policy Review?

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Attorney Arnold Friede says FDA appears to be breaking new enforcement ground in requiring a repeat offender of advertising violat...