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Probe FDA Cozy Relationship with Pharma: Rep. Harris

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Rep. Andy Harris calls for an investigation to determine whether an FDA cozy relationship with the drug industry led to a 10-year ...

Restrict ANDAs for Generic Zoryve: Arcutis

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Arcutis asks FDA to restrict approvals of any ANDA citing its Zoryve psoriasis cream as the reference-listed drug.

eSTAR e-Submissions Open for PMAs

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FDA opens its eSTAR electronic submission template for voluntary use for certain PMA submissions.

CBER Helping to Speed Gene Therapies: Marks

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CBER director Peter Marks outlines his Centers plans to speed gene therapy development, such as through FDA-encouraged harmonizati...

Opdivo sBLA for Bladder Cancer

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FDA accepts for priority review a Bristol Myers Squibb (BMS) supplemental BLA for Opdivo (nivolumab) for combination use with cisp...

Animal Drug Regulations Amended

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Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions during July, August, and Se...

Industry Concerns with Predicate Device Guide

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Three medical device industry stakeholders raise multiple legal and regulatory concerns with an FDA draft guidance on choosing an ...

Belmont Eyecare Selling Unapproved Eye Drops: FDA

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FDA warns Chicago, IL-based Belmont Eyecare it is illegally marketing six types of eye drops that are unapproved new drugs.

MONARCH 3 Results Show Verzenio Success: Lilly

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Lilly says that MONARCH 3 trial results indicate its Verzenio plus an aromatase inhibitor had a better survival rate than the cont...

How FDA One-stop PJOs Help Combo Industry

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A recent conference panel describes how FDA Product Jurisdiction Officers provide one-stop communication and coordination services...