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FDA Clears DSM Bio Radiopaque Cerclage Cable

[ Price : $8.95]

FDA clears a DSM Biomedical 510(k) for the Dyneema Purity Radiopaque Cerclage Cable for use in orthopedic trauma treatments, such ...

Guidance on FDA-IND Sponsor Communications

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance: Best Practices for Communication Between IND Sponsors and FDA During Drug ...

Comments Reopened on Genetic Tests

[ Price : $8.95]

Federal Register Notice: FDA reopens the comment period on a public workshop discussing the use of databases that link human genet...

Panel to Discuss Treatment for Opioid Dependence

[ Price : $8.95]

Federal Register Notice: FDAs Psychopharmacologic Drugs Advisory Committee will meet 1/12/16 to discuss a Titan Pharmaceuticals ND...

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

[ Price : $8.95]

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

[ Price : $8.95]

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