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Stakeholders Comment on Cyclosporine Letter

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Allergan says FDA should not think it can be talking with ANDA first applicants for generic Restasis because no generic drug compa...

Harmonized Benefit/Risk Info Guidance

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FDA publishes a draft International Conference on Harmonization guidance on enhancing the format and structure of benefit-risk inf...

Issues Raised with FDA PDUFA Meeting Guidance

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BIO says an FDA draft guidance on formal meetings between the agency and sponsors of PDUFA products will give additional clarity.

Dissolution Testing Guidance Welcome

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Companies welcome an FDA guidance on dissolution testing and raise additional concerns.

FDA Centers Give Updates on Promotion Violations

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Presentations by CDER, CBER and CDRH advertising and promotion officials discuss current issues and violations observed at the age...

Justice Department Focusing on Individual Accountability: Official

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Justice Department Consumer Protection Branch assistant director Jill Furman says individual accountability for corporate wrongdoi...

Public Citizen Blasts NEJM Ethics

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Public Citizens Michael Carome says the New England Journal of Medicine breached its own ethics by publishing a commentary that gr...

FDA Approves BMS Opdivo/Yervoy for Melanoma

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FDA approves a Bristol-Myers Squibb NDA for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for treating patients with ...

Allergan Gains Approval for Juvederm Lip Augmentation

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FDA approves an Allergan PMA to market Juvederm Ultra XC, a dermal filler for injection into the lips and perioral area for lip au...

Panel to Discuss Fluroquinolone Antibacterials

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Federal Register Notice: FDAs Antimicrobial Drugs and the Drug Safety and Risk Management Advisory Committees will discuss 11/5 sy...