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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: FDAís 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 Resubmission Drug App Classification MAPP [373 Words] [ Price : $8.95]
The CDER Office of New Drugs issues a MAPP on classifying drug application resubmissions received in response to a complete response letter.
02/26/2015
 
 
TXT Otonomy Files NDA for Middle Ear Effusion Drug [90 Words] [ Price : $8.95]
Otonomy files an NDA for AuriPro as a treatment for middle ear effusion in pediatric patients undergoing tympanostomy tube placement surgery.
02/26/2015
 
 
TXT House Bill to Shield FDA User Fees During Sequestration [221 Words] [ Price : $8.95]
Reps. Anna G. Eshoo (D-CA) and Leonard Lance (R-NJ) reintroduce the FDA Safety Over Sequestration Act, which exempts agency user fees from any future sequestration actions.
02/26/2015
 
 
TXT Sandoz, Amgen Battle in Court Over Neupogen Biosimilar [521 Words] [ Price : $8.95]
As the user fee review target date of 3/8 approaches, Sandoz faces a major court hurdle before it gains approval to market the first biosimilar product in the U.S.ó a copy of Amgenís Neupogen (filgrastim).
02/26/2015
 
 
TXT Courts Miss Off-Label Truthful Promos Test: Attorney [449 Words] [ Price : $8.95]
Attorney Michelle Yeary says courts sometimes donít distinguish between truthful and untruthful off-label promotion claims in determining liability for fraud or negligence.
02/26/2015
 
 
TXT Jury Awards $2.5M In Risperdal Breast Enlargement Case [308 Words] [ Price : $8.95]
A Philadelphia jury awards a man $2.5 million for his claim that Janssen failed to warn him sufficiently that taking Risperdal could cause him to grow female-like breasts.
02/26/2015
 
 
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