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Guidance on BE Recommendations on Paliperidone Palmitate

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Federal Register Notice: FDA releases a revised draft guidance: Bioequivalence Recommendations for Paliperidone Palmitate.

Maverick FDA Reviewer Marciniak on Broken Trial Process: BMJ

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Outspoken FDA reviewer Thomas Marciniak takes to the BMJ (formerly the British Medical Journal) to detail how the clinical trial p...

FDA External Affairs Chief Leaving Agency

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FDA associate commissioner for external affairs Virginia Cox leaves the agency next month to pursue other opportunities.

FDA Orphan Status for Dyax Angioedema Drug

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FDA grants Dyax an orphan drug designation for DX-2930, a fully human monoclonal antibody inhibitor of plasma kallikrein for use i...

FDA Clears Ventana Estrogen Receptor Image Analysis Algorithm

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FDA clears a Ventana Medical Systems 510(k) for the Companion Algorithm Estrogen Receptor image analysis algorithm used with the V...

11 Medication Guides Updated

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FDA releases updates to 11 Medication Guides.

FDA Needs to Set Reproductive Cloning Authority: Attorney

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Attorney Arnold Friede says FDA should start a deliberate process to gain stakeholder input and develop a regulatory rationale for...

Guidance on Pharmacy Compounding

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Federal Register Notice: FDA releases a draft guidance: Pharmacy Compounding of Human Drug Products Under Section 503A of the Fede...

Nominations Sought for Bulk Drug List for Compounding

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Federal Register Notice: FDA requests nominations for specific bulk drug substances be part of an agency-developed list that may b...

FDA Seeks Nominations for Difficult-to-Compound Drugs

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Federal Register Notice: FDA requests nominations for specific drug products or categories to help the agency develop a list of di...