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Guidance on Premarket Requirements for Health Care Gowns

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance: Premarket Notification Requirements Concerning Gowns Intended for Use in Health ...

Comments Reopened on Human Genome Workshop

[ Price : $8.95]

Federal Register Notice: FDA reopens the comment period on a public workshop on standards-based regulatory strategy for next-gener...

Amgen Wins Injunction in Biosimilar Case Against Apotex

[ Price : $8.95]

Amgen wins a preliminary injunction against Apotex over notification of when Apotex intends to market its biosimilar version of Ne...

Institutional Investors Want Biosimilar Same Labeling

[ Price : $8.95]

Some 15 institutional investors ask FDA to require the same labeling for biosimilars as for their reference products and to hold a...

PwCs Top 10 Health Issues for 2016

[ Price : $8.95]

PwC says that merger mania will be one of the 10 top health industry issues in 2016.

2 Firms Selling Unapproved Genetic Tests: FDA

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FDA says that two firms are marketing DTC genetic tests without agency clearance.

CDRH Proposes User Fee Program Enhancements

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A recent medical device user fee negotiation meeting sees CDRH proposing numerous program enhancements to improve consistency and ...

FDA Should Reverse Dispute Resolution Stance: Attorneys

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Hyman, Phelps & McNamara asks FDA to reverse a recent guidance limiting the way drug sponsors can appeal FDA decisions they believ...

Medisca API Improperly Labeled: FDA

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FDAs New York District Office warns Medisca about mislabeled APIs intended for use by compounding pharmacies and other violations....

Public Citizen Hits Orphan Drug Incentive Proposal

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Public Citizen blasts a 21st Century Cures provision to reward companies with longer patent periods and higher prices for branded ...