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FDA Publishes CBER PMAs

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Federal Register Notice: FDA publishes a list of PMAs approved by CBER.

FDA Clears RTX Telehealth Monitor

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FDA clears a RTX Healthcare 510(k) for the RTX3370 Telehealth Monitor, a wireless device for elderly patients that collects vital ...

Experimental Drug Court Battle to Go On

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Abigail Alliance says it will ask the U.S. Supreme Court to decide whether terminally ill patients have a constitutional right to ...

Mylan Wants Fentanyl Stay

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Mylan asks FDA not to approve any applications for fentanyl transdermal systems until it rules on the companys request for studies...

Takeda Seeks Block on Actos Generics with Carved-out Labeling

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Takeda petitions FDA to block ANDA approvals of generic copies of diabetes drug Actos if the labeling approved has been carved out...

FDA Pre-approval Audit for BSD Medical PMA

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FDA completes a pre-approval audit for a BSD Medical Corp. PMA for the BSD-2000 hyperthermia system.

New Sunscreen Rule Proposed

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FDA proposes a new rule creating a consumer-friendly four-star rating system for UVA protection in OTC sunscreens.

FDA Needs More Time on rThrombin BLA Review

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FDAs extends by three months its review of a ZymoGenetics BLA for surgical blood-clotting agent rThrombin.

Ultra Botanicals Cautioned on Web Marketing

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FDA says a Web site for Ultra Botanicals promotes products that are considered new drugs and dont have the required FDA approvals....

Court Backs FDA Preemption in State Rx Ad Fraud Cases

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An appeals court rules that state consumer fraud laws are federally preempted in legal matters involving prescription drug adverti...