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TXT Innovative Device Approvals Speeded Up: Analysis [356 Words] [ Price : $8.95]
An Ep Vantage analysis says that the number of innovative medical devices approved by FDA in 2014 was higher than the number approved in 2013, and approval times were shorter.
01/27/2015
 
 
TXT Praise for Revised SOFTWARE Act [376 Words] [ Price : $8.95]
Stakeholders reportedly say that a revised version of the SOFTWARE bill is clearer and more focused in defining what FDA will and will not regulate in terms of medical and health software.
01/27/2015
 
 
TXT Duke’s Califf Appointed as FDA Deputy Commissioner. [1416 Words] [ Price : $8.95]
FDA appoints Duke University vice chancellor of clinical and translational research Robert Califf as its next deputy commissioner for medical products and tobacco.
01/26/2015
 
 
TXT Ex-FDA Head Kessler Ready to Testify Against J&J [1537 Words] [ Price : $8.95]
Former FDA commissioner David Kessler appears to be getting his day in court to testify as an expert witness against Johnson & Johnson and its marketing practices involving the antipsychotic drug Risperdal.
01/26/2015
 
 
TXT Pharmacy Compounding Panel to Meet [210 Words] [ Price : $8.95]
Federal Register Notice: FDA’s Pharmacy Compounding Advisory Committee will meet 2/23-24 to discuss revisions to the list of drug products that may not be compounded.
01/26/2015
 
 
TXT Panel to Discuss NDA for Improving Appearance of Submental Fat [122 Words] [ Price : $8.95]
Federal Register Notice: FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee will discuss 3/9 atopic dermatitis treatments and a Kythera Biopharma NDA for improving convexity associated with submental fat.
01/26/2015
 
 
TXT FDA Approves First Generic Nexium; Rules Against Ranbaxy [179 Words] [ Price : $8.95]
FDA approves the first generic version of AstraZeneca’s Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease.
01/26/2015
 
 
TXT Turkish Man Sentenced for Smuggling Counterfeit Drugs [168 Words] [ Price : $8.95]
A federal judge sentences a Turkish man for his role in smuggling counterfeit cancer drugs into the U.S.
01/26/2015
 
 
TXT FDA Post ICH Guidance on Drug Photosafety Assessments [1170 Words] [ Price : $8.95]
FDA posts an International Conference on Harmonization guidance on S10 Photosafety Evaluation of Pharmaceuticals.
01/26/2015
 
 
TXT FDA Guidance on Combination Product GMP Compliance [1385 Words] [ Price : $8.95]
FDA releases a draft guidance on Current Good Manufacturing Practice Requirements for Combination Products that describes and explains a 2013 final rule on CGMP requirements for such products.
01/26/2015
 
 
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