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FDA Posts Sept, Oct NADAs, ANADAs

[ Price : $8.95]

Federal Register Final rule: FDA amends the animal drug regulations to reflect September and October application-related actions f...

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

[ Price : $8.95]

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 ...

Progress in PDUFA 6 Talks

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FDA releases minutes describing progress made during discussions with industry at three PDUFA 6 steering committee meetings and on...

Dignitana Cooling Cap Cleared for Reducing Chemo Hair Loss

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FDA clears a Dignitana de novo petition to allow marketing of the DigniCap Cooling System, a cooling cap designed to reduce hair l...