HOME ABOUT US PRINT PUBLICATIONS SUBSCRIPTIONS CONTACT US TELL FRIEND RSS
 
Welcome to FDAweb
Pay Per View
Search our 52,565 - story database FREE
 
Free Items
 Warning Letters
 FDA Notices
 FDA Calendar
 

 FDA Whistleblowers



    








 
 
<< Prev  13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 Next >>
 
TXT FDA OKs Kythera Bio NDA for Treating Chin Fat [189 Words] [ Price : $8.95]
FDA approves a Kythera Biopharmaceuticals NDA for Kybella (deoxycholic acid), a treatment for adults with moderate-to-severe fat below the chin (submental fat).
04/30/2015
 
 
TXT Senate HELP Republicans Want Biosimilar Clarity [574 Words] [ Price : $8.95]
Eight Senate HELP Committee Republicans say FDA should immediately finalize all pending guidance on the biosimilar approval pathway.
04/30/2015
 
 
TXT FDA Warns of Possible Inaccurate Mammograms [72 Words] [ Price : $8.95]
FDA alerts patients who had a mammogram at the Coastal Diagnostic Center in Pismo Beach, CA to possible inaccuracies.
04/30/2015
 
 
TXT FDA OKs St. Jude Medical Spinal Cord Stimulator [73 Words] [ Price : $8.95]
FDA approves St. Jude Medical’s Protégé MRI spinal cord stimulation system for managing chronic pain.
04/30/2015
 
 
TXT Guidance on Therapeutic Protein Product Biosimilarity [94 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product.
04/30/2015
 
 
TXT Guidance on Demonstrating Biosimilarity [84 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.
04/30/2015
 
 
TXT Guidance on Biosimilars Q&A [98 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.
04/30/2015
 
 
TXT Panel to Discuss Sanofi’s Praluent [136 Words] [ Price : $8.95]
Federal Register Notice: FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet 6/9 to discuss a Sanofi-Aventis U.S. BLA for Praluent for primary hypercholesterolemia or mixed dyslipidemia.
04/30/2015
 
 
TXT Panel to Discuss Opioid Addiction Treatment Labeling for Fetal Effects [115 Words] [ Price : $8.95]
Federal Register Notice: FDA’s Risk Communications Advisory Committee will meet 6/8-9 to discuss labeling for methadone or buprenorphine maintenance therapy for opioid addiction and the effects on a fetus.
04/30/2015
 
 
TXT Panel to Discuss Amgen BLA for Cholesterol [195 Words] [ Price : $8.95]
Federal Register Notice: FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet 6/10 to discuss Amgen’s Repatha for reducing cholesterol.
04/30/2015
 
 
<< Prev  13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32  Next >>
 

FERDIC INCORPORATED - P.O. Box 28, Camp Hill, PA 17001 | Phone: (717)731-1426 fax:(717)731-1427 Email: info@fdaweb.com
_