HOME ABOUT US PRINT PUBLICATIONS SUBSCRIPTIONS CONTACT US TELL FRIEND RSS
 
Welcome to FDAweb
Pay Per View
Search our 45,899 - story database FREE
 
Free Items
 Warning Letters
 FDA Notices
 FDA Calendar
 

 FDA Whistleblowers



    








 
 
<< Prev  1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Next >>
 
TXT Momenta Argues for Supreme Court Lovenox Case Review [212 Words] [ Price : $7.95]
Momenta argues the need for Supreme Court review of a Federal Circuit ruling against it in a Lovenox case.
06/06/2013
 
 
TXT Biodel to Submit IND for Severe Hypoglycemia [155 Words] [ Price : $7.95]
Biodel plans to submit an IND to FDA to study its glucagon therapy for treating severe hypoglycemia.
06/06/2013
 
 
TXT LAM Therapeutics to Develop Drugs for Rare Lung Disease [111 Words] [ Price : $7.95]
LAM Therapeutics begins its operations to identify clinical stage drugs to treat Lymphangioleiomyomatosis (LAM), a rare lung disease.
06/06/2013
 
 
TXT FDA Agrees to Accelerated Development for Avanir Drug [167 Words] [ Price : $7.95]
FDA agrees to an expedited pathway for Avanir Pharmaceuticals’investigational compound AVP-786, which is being developed for central nervous system disorders.
06/05/2013
 
 
TXT FDA Priority Review for Metabolic Disorder BLA [204 Words] [ Price : $7.95]
FDA accepts for priority review a Bristol-Myers Squibb and AstraZeneca BLA for metreleptin, an investigational agent for treating metabolic disorders associated with inherited or acquired lipodystrophy.
06/05/2013
 
 
TXT Violations Found in Validus Marplan Web Page [369 Words] [ Price : $7.95]
CDER’s Office of Prescription Drug Promotion says a Validus Pharmaceuticals Web page for Marplan is false and misleading due to unsubstantiated superiority claims and other violations.
06/05/2013
 
 
TXT PhRMA Wants Separate Biosimilar Reviewers [221 Words] [ Price : $7.95]
PhRMA asks that FDA medical reviewers who worked on reference products not work on biosimilars for those products.
06/05/2013
 
 
TXT Roth says OCI Enforcement Actions are Deterrent [400 Words] [ Price : $7.95]
OCI director John Roth blogs about two cases that should deter other companies from illegal conduct.
06/05/2013
 
 
TXT Carefully Negotiate Drug Quality Agreements: Attorneys [169 Words] [ Price : $7.95]
Alston & Bird attorneys caution drug owners and contract facilities to carefully negotiate quality agreements to meet FDA expectations.
06/05/2013
 
 
TXT House Committee Mark Up Gives FDA $100 Million Boost [201 Words] [ Price : $7.95]
A House Appropriations Committee mark up proposes to give FDA almost $100 million more in fiscal year 2014 than the current sequester-imposed budget authority.
06/05/2013
 
 
<< Prev  1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20  Next >>
 

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