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Actavis Sued Over ANDA for Generic Copy of Absorica

[ Price : $8.95]

Actavis files an ANDA seeking approval to market a generic copy of Ranbaxys Absorica (isotretinoin) capsules, and the company is s...

Feds Seeking Info on AstraZeneca PLATO Trial

[ Price : $8.95]

AstraZeneca says it has received a civil investigative demand from the U.S. Department of Justice seeking documents and informatio...

Pentax Medical Recalls Gas/Water Valves

[ Price : $8.95]

Pentax Medical has recalled 76 Pentax Gas/Water Valves, model OF-B194, that are used with the companys GI Video Endoscopes.

Hatchtech Plans NDA Submission for Lice Treatment

[ Price : $8.95]

Hatchtech says it is planning a Phase 3 trial involving head lice treatment DeOvo (Ha44) to support an NDA submission planned for ...

FDA Proposes Rule for Some Drug Shortage Notifications

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FDA issues a strategic plan and proposes a new early notification rule to help address potential drug shortages

Comments Sought on Adolescent DTC Promotion Info

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Federal Register Notice: FDA seeks comments on a proposed collection of information on direct-to-consumer promotion directed at ad...

Info on Electronic Products Sent to OMB

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Federal Register Notice: FDAs submits a proposed collection of information on electronic products to the Office of Management and ...

Info on Device Presubmission Program Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a guidance on ...

Info on BLA General Licensing Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection on general licensing provisions for BLAs to the Office of Management an...

FDA Submits Info on IND Safety Reporting to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits to the Office of Management and Budget a proposed collection of information on investigationa...