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TXT Workshop on Office of Regulatory Science and Innovation [120 Words] [ Price : $8.95]
Federal Register Notice: FDA plans a public workshop 4/27: “The 2015 Office of Regulatory Science and Innovation (ORSI) Science Symposium.”
02/27/2015
 
 
TXT FDA OKs Actavis/Medicines360’s Liletta IUD [90 Words] [ Price : $8.95]
FDA approves Actavis and Medicines360’s Liletta, an intrauterine device indicated to continuously release levonorgestrel to prevent pregnancy for up to three years.
02/27/2015
 
 
TXT Groups Critique Flow Cytometric Device Guidance [426 Words] [ Price : $8.95]
AdvaMedDx tells FDA it should reference the use of scientific literature in addition to performance studies using clinical samples in its guidance document on Flow Cytometric Devices.
02/27/2015
 
 
TXT Is it Data ‘Integrity’ or Data ‘Fraud?’ [457 Words] [ Price : $8.95]
Writing in an online article, Generapharm managing director Malcolm Ross suggests that FDA needs to use harsher terminology when it uncovers serious and questionable data integrity at pharmaceutical manufacturing facilities.
02/27/2015
 
 
TXT FDA Progress Report on Judicious Use of Antimicrobials [170 Words] [ Price : $8.95]
FDA releases the second progress report on its strategy to promote the judicious use of antimicrobials in food-producing animals.
02/27/2015
 
 
TXT Fight Industry Pressure on Generic Drug Rule: Public Citizen [325 Words] [ Price : $8.95]
Public Citizen says FDA should not allow the drug industry to pressure it and delay its proposal on giving generic drug manufacturers the ability to update labeling to provide warnings about newly discovered risks.
02/27/2015
 
 
TXT Panel to Discuss Medicines Co. NDA [92 Words] [ Price : $8.95]
Federal Register Notice: FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet 4/15 to discuss an NDA for reducing thrombotic cardiovascular events in patients undergoing percutaneous coronary intervention.
02/27/2015
 
 
TXT FDA Amends E-Device Reporting Regs [52 Words] [ Price : $8.95]
Federal Register Final rule: FDA is amending its regulation on postmarket electronic Medical Device Reporting to address the unintentional removal of provisions of the Unique Device Identification System regulations.
02/27/2015
 
 
TXT FDA Approves Actavis NDA for Avycaz [98 Words] [ Price : $8.95]
FDA approves an Actavis NDA for Avycaz (ceftazidime-avibactam) for treating adult patients with complicated intra-abdominal infections.
02/26/2015
 
 
TXT Petition Asks FDA Action Against Bayer’s Essure [689 Words] [ Price : $8.95]
A Florida law firm asks FDA to suspend its PMA approval for Bayer’s Essure and take other actions against the medical device due to company violations of PMA provisions.
02/26/2015
 
 
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