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DOR BioPharma Receives Guidance From FDA on Proposed Confirmatory Phase 3 Clinical Trial Design of orBec in GI GVHD
DOR BioPharma, a late-stage biopharmaceutical company developing products to treat the life-threatening side effects of cancer treatments and serious ...

FDA's J. David Doleski and Nicole Trudel to Co-Present at 2009 PDA Annual Meeting
The Parenteral Drug Association (PDA) has confirmed that FDA's J. David Doleski and Nicole Trudel will co-present during the Opening Plenary Session a...

ReGen Biologics 510(k) to be Considered by FDA Orthopaedic Panel
ReGen Biologics announced that the Food and Drug Administration ("FDA") has scheduled a meeting of the Orthopaedic and Rehabilitation Devices Advisory...

BioDelivery Sciences to Meet with FDA to Finalize Proposed REMS for ONSOLIS
BioDelivery Sciences International, Inc., (Nasdaq:BDSI) announced that a meeting with the Food and Drug Administration (FDA) is scheduled for November...

Cardo Medical Announces FDA Clearance of the Align 360 Total Knee System
Cardo Medical, a company engaged in the development of orthopedic medical devices, announces the FDA 510k clearance of its Align 360 Total Knee System...

Caraco Pharmaceutical Laboratories, Ltd. Receives FDA Warning Letter
On October 31, 2008, Caraco Pharmaceutical Laboratories, Ltd. (NYSE Alternext US: CPD) received a warning letter from the FDA. The letter was issued a...

Wolters Kluwer Health's Unique Prescription Data Tapped by FDA in Effort to Advance Drug Safety
Wolters Kluwer Health, a leadingprovider of information and business intelligence for students, professionalsand institutions in medicine, nursing, al...

ACC Statement Regarding the FDA Science Board Subcommittee Report on Bisphenol A
In response to the report from the Food and Drug Administration's Science Board Subcommittee concerning a review of the FDA's draft assessment of bisp...

Cardo Medical Announces FDA Clearance of the Align 360 Total Knee System
Cardo Medical, a company engaged in the development of orthopedic medical devices, announced the FDA 510k clearance of its Align 360 Total Knee System...

Consumers Union Urges FDA to Conduct Full Scale Safety Review of Nanoparticles in Sunscreen
Consumers Union, nonprofit publisher of Consumer Reports, today released new product tests showing that 4 out of 5 sunscreens that claimed not to cont...

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