HOME ABOUT US PRINT PUBLICATIONS SUBSCRIPTIONS CONTACT US TELL FRIEND RSS
 
Welcome to FDAweb
Pay Per View
Search our 52,221 - story database FREE
 
Free Items
 Warning Letters
 FDA Notices
 FDA Calendar
 

 FDA Whistleblowers



    








 
 
<< Prev  15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 Next >>
 
TXT FDA Orphan Status for Investigational ALS Drug [105 Words] [ Price : $8.95]
FDA grants AB Science an orphan drug designation for masitinib and its use in treating amyotrophic lateral sclerosis.
03/23/2015
 
 
TXT Petition Seeks Withdrawal of Prenatal Drugs [282 Words] [ Price : $8.95]
A citizen petition asks FDA to withdraw approval for 17-alpha hydroxyprogesterone caproate drugs, including K-V Pharmaceutical’s prenatal drug Makena, and their use in pregnant women until a fetal safety assessment is conducted.
03/23/2015
 
 
TXT Pfizer, Lilly Resume Pain Drug Studies [175 Words] [ Price : $8.95]
Pfizer and Eli Lilly say they are resuming a Phase 3 clinical program for pain drug tanezumab that has been on clinical hold since 2012.
03/23/2015
 
 
TXT Insect Bite Device into Class 2 [51 Words] [ Price : $8.95]
Federal Register Final order: FDA classifies the limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites into Class 2.
03/23/2015
 
 
TXT FDA Approves Abiomed PMA for Impella Blood Pump [200 Words] [ Price : $8.95]
FDA approves an Abiomed PMA for the Impella 2.5 System, a miniature blood pump system intended to help certain patients maintain stable heart function and circulation during certain high-risk percutaneous coronary intervention procedures.
03/23/2015
 
 
TXT Gilead Seeks Dismissal of Suit on Alleged FDA Violations [217 Words] [ Price : $8.95]
Gilead Sciences files a motion in Northern California federal court to dismiss a whistleblower-filed False Claims Act lawsuit that alleged FDA regulatory violations and “adulterated” products.
03/23/2015
 
 
TXT Federal Judge Sides with Sandoz and its Biosimilar Product [445 Words] [ Price : $8.95]
A northern California federal judge rejects an Amgen bid to delay Sandoz’s market introduction of the first biosimilar product approved in the U.S. — a copy of Amgen’s Neupogen (filgrastim).
03/20/2015
 
 
TXT Guidance on e-Submissions for BLA Lot Distribution Reports [85 Words] [ Price : $8.95]
FDA posts a guidance on “Electronic Submission of Lot Distribution Reports” that provides information and recommendations on e-submissions of BLA-related lot distribution reports.
03/20/2015
 
 
TXT Antiviral Drugs Panel Terminated [82 Words] [ Price : $8.95]
Federal Register Final rule: FDA terminates the Antiviral Drugs Advisory Committee.
03/20/2015
 
 
TXT FDA OKs Biotronik Eluna Pacemaker System [132 Words] [ Price : $8.95]
FDA approves Biotronik’s ProMRI Eluna pacemaker system to allow patients with both single and dual-chamber Eluna pacemakers to undergo full-body MRI scans.
03/20/2015
 
 
<< Prev  15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34  Next >>
 

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