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TXT Hearing On Generic Drug User Fees [90 Words] [ Price : $8.95]
Federal Register Notice: FDA plans a public hearing 9/17 on certain topics related to implementation of the Generic Drug User Fee Amendments of 2012 and the GDUFA commitment letter.
08/19/2014
 
 
TXT Law Firm Urges Industry to Reject 510(k) Benefit-Risk Guidance [688 Words] [ Price : $8.95]
Duval & Associates urges the Advanced Medical Technology Association (AdvaMed) and Medical Device Manufacturers Association to oppose CDRH’s recent draft guidance on 510(k) benefit-risk factors.
08/18/2014
 
 
TXT Boxed Warnings Becoming More Prevalent on Drugs: Researchers [191 Words] [ Price : $8.95]
Researchers writing in the 8/15 issue of JAMA Internal Medicine say boxed warnings on drugs are becoming more common.
08/18/2014
 
 
TXT CDER Drug Safety Board Reviews Anticoagulants [252 Words] [ Price : $8.95]
CDER’s Drug Safety Oversight Board reviews safety implications from new generation anti-coagulants.
08/18/2014
 
 
TXT Editorial Wants FDA Out of Compassionate-use Approvals [215 Words] [ Price : $8.95]
A USA Today editorial argues for quicker and less cumbersome — no FDA role — compassionate-use opportunities for patients suffering from terminal illnesses.
08/18/2014
 
 
TXT FDA Guidance on IDE Decisions to Allow Trials to Begin [419 Words] [ Price : $8.95]
FDA releases a guidance on FDA Decisions for Investigational Device Exemption Clinical Investigations that is intended to facilitate the initiation of clinical investigations under an IDE.
08/18/2014
 
 
TXT Alabama Court Reaffirms Brand Liability in Generic Drug Harm Suits [217 Words] [ Price : $8.95]
The Alabama Supreme Court re-affirms that patients can sue brand drug makers for fraud or misrepresentation when plaintiffs are injured by a generic drug.
08/18/2014
 
 
TXT Pfizer NDA for Palbociclib for Breast Cancer [196 Words] [ Price : $8.95]
Pfizer submits an NDA for palbociclib for use in combination with letrozole for treating postmenopausal women with a certain advanced breast cancer.
08/18/2014
 
 
TXT FDA Rules for Labeling ‘Use Code’ Carve Outs for ANDAs [380 Words] [ Price : $8.95]
FDA deals brand drug makers a blow on “use codes” listed in the Orange Book and their use for market protection by allowing generics to “carve out” protected labeling.
08/18/2014
 
 
TXT Baxter Recalls 2 Dianeal Lots Over Particulate Concern [140 Words] [ Price : $8.95]
Baxter International recalls two lots of Dianeal low calcium (2.5mEq/L) peritoneal dialysis solution with 2.5% dextrose 5,000mL due to the presence of particulate matter identified during the manufacturing process.
08/15/2014
 
 
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