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TXT FY 2016 Device User Fees Set [217 Words] [ Price : $8.95]
Federal Register Notice: FDA sets the fee rates and payment procedures for medical device user fees for fiscal year 2016.
08/03/2015
 
 
TXT FDA Sends Info to OMB on Outsourcing Facility AE Reporting [56 Words] [ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a guidance on adverse event reporting for outsourcing facilities.
08/03/2015
 
 
TXT Unichem Pharmaceuticals Recalls Hydrochlorothiazide Tablets [103 Words] [ Price : $8.95]
Unichem Pharmaceuticals recalls one lot of hydrochlorothiazide tablets 25 mg 1,000-count bottle after a clopidogrel tablet was found in a bottle of the product.
08/03/2015
 
 
TXT FDA Sets FY 2016 Prescription Drug User Fees [63 Words] [ Price : $8.95]
Federal Register Notice: FDA sets the fiscal year 2017 user fee rates for prescription drugs.
08/03/2015
 
 
TXT Guidance on Human Leukocyte Antigen Test 510(k)s [133 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a guidance on 510(k) submissions for nucleic Acid-based human leukocyte antigen test kits used for matching donors and recipients in transfusion and transplantation.
08/03/2015
 
 
TXT FDA Approves Bayer’s Finacea for Rosacea [135 Words] [ Price : $8.95]
FDA approves a Bayer HealthCare NDA for Finacea (azelaic acid 15%) Foam for topical treatment of inflammatory papules and pustules of mild to moderate rosacea.
07/31/2015
 
 
TXT Draft Guide on Dissolution Testing, Specification Criteria [80 Words] [ Price : $8.95]
FDA posts a draft guidance on Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs.
07/31/2015
 
 
TXT ADMA Biologics BLA for Primary Immunodeficiency [232 Words] [ Price : $8.95]
ADMA Biologics files a BLA for RI-002, and investigational therapy for treating primary immunodeficiency patients.
07/31/2015
 
 
TXT NuVasive Settles Device Unapproved Use Charges [252 Words] [ Price : $8.95]
California-based medical device maker NuVasive agrees to pay the U.S. government $13.5 million to resolve allegations that it caused health care providers to submit false claims to Medicare and other federal health care programs for spine surgeries by marketing its CoRoent System for surgical uses that were not approved by FDA.
07/31/2015
 
 
TXT Guidance on Stability Testing for New Veterinary Drugs [126 Words] [ Price : $8.95]
Federal Register Notice: FDA releases an ICH guidance: Bracketing and Matrixing Designs for Stability Testing of New Veterinary Drug Substances and Medicinal Products.
07/31/2015
 
 
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