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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.
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Advanced Medical Technology Association (AdvaMed) and Medical Device Manufacturers Association to oppose CDRH’s recent draft guidance on 510(k) benefit-risk factors.
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.
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.
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.
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.
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.
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.
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.
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.
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