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TXT Comments Sought on OTC Drug Classification Criteria [4 Words] [ Price : $8.95]
Federal Register Notice: FDA seeks comments on a proposed collection of information on criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded.
03/24/2014
 
 
TXT Panel to Discuss 1st Immediate-Release Opiod Combo [111 Words] [ Price : $8.95]
Federal Register Notice: FDA’s Anesthetic and Analgesic Drug Products Advisory Committee will meet 4/22 to discuss QRxPharma’s Moxduo the first drug combination of two immediate-release opioids.
03/24/2014
 
 
TXT FDA Approves 3 St. Jude Pacemakers [163 Words] [ Price : $8.95]
FDA approves three St. Jude Medical pacemakers — the Allure Quadra Cardiac Resynchronization Therapy Pacemaker, Assurity pacemaker and Endurity pacemaker.
03/24/2014
 
 
TXT Case Extends Preemption to 510(k)-Cleared Device [316 Words] [ Price : $8.95]
The New York Eastern federal court extends preemption to a device case that involved off-label use even though the product didn’t receive PMA approval from FDA.
03/24/2014
 
 
TXT FDA Draft Guidance on Accelerated Approval Labeling [211 Words] [ Price : $8.95]
FDA posts a new draft guidance to help sponsors develop their “Indications and Usage” labeling for drug and biologic products approved under the accelerated approval regulatory pathway.
03/24/2014
 
 
TXT Selectors/Nominations Sought for Advisory Panel Consumer Reps [80 Words] [ Price : $8.95]
Federal Register Notice: FDA seeks participants for selecting as well as nominations for voting/non-voting consumer representatives to serve on its advisory committee panels.
03/24/2014
 
 
TXT Groups Weigh In on Adding Products to ‘Difficult to Compound’ List [407 Words] [ Price : $8.95]
BIO says FDA should not allow compounding of any biological products for both traditional and outsourcing pharmacy compounding operations.
03/24/2014
 
 
TXT FDA Grants Final Approval for Lupin’s Niacin ER [84 Words] [ Price : $8.95]
FDA grants final approval of Lupin Pharmaceuticals’ niacin-extended release tablets, a generic equivalent of AbbVie’s Niaspan tablets indicated to treat high cholesterol.
03/21/2014
 
 
TXT Forest Reports Positive Results for Antipsychotic [104 Words] [ Price : $8.95]
Forest Laboratories and Gedeon Richter report positive Phase 2b trial results for the antipsychotic cariprazine in adults with Major Depressive Disorder.
03/21/2014
 
 
TXT Two Guidances Released on Electrosurgical Device 510(k)s [111 Words] [ Price : $8.95]
CDRH posts two electrosurgical device draft guidances to help device makers prepare 510(k) submissions.
03/21/2014
 
 
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