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Childrens Medical Recalls Infant Head Spports

[ Price : $8.95]

Childrens Medical Ventures has recalled its Gel-E Donut and Squishon 2 gel-filled infant head supports due to complaints about mol...

Risk Minimization, Omission Most Common Drug Ad Issue

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Eye-on-FDA blogger Mark Senak says that his analysis of drug promotion Warning and Untitled Letters over a decade shows that risk ...

CDRH OKs Type 1 Diabetes Test

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CDRH approves a de novo petition to allow marketing of Kronus Market Development Associates zinc transporter 8 autoantibody (ZnT8A...

Pfizer Starts Expanded Access Program for Palbociclib

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Pfizer begins a multi-center, expanded access trial for its investigational therapy palbociclib in certain women with advanced bre...

DEA Rescheduling Hydrocodone Combination Products

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The Drug Enforcement Administration explains why it has decided to reschedule hydrocodone combination products from Schedule 3 to ...

Reject Teva Petition on Rescue Inhaler Counters: Mylan

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Mylan urges FDA to deny a Teva petition that would impose testing requirements on sponsors of ANDAs for rescue inhalers with integ...

Concerns About FDA Regulating Through Guidance

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Attorney Gail Javitt says FDAs plan to regulate clinical laboratories and laboratory-developed tests through two guidances violate...

FDA Enhancing Trial Data Collection, Availability

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FDA commissioner Margaret Hamburg says the agency is issuing an action plan and guidance to improve collection and reporting of cl...

FDA Proposing Master Protocol for Breast Cancer Trials

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FDA coordinates a public workshop to advance a proposed master protocol for conducting trials in patients with metastatic breast c...

FDA Sends Info on Temporary Marketing Permits to OMB

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Federal Register Notice: FDA submits a proposed collection of information on temporary marketing permit applications to the Office...