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TXT Class 2 for Computerized Concussion Assessment Aids [70 Words] [ Price : $8.95]
Federal Register Final Order: FDA classifies Computerized Cognitive Assessment Aids for Concussion into Class II (special controls).
12/06/2016
 
 
TXT Biomarker Evidentiary Criteria Framework Released [249 Words] [ Price : $8.95]
The Foundation for the National Institutes of Health issues its Framework for Defining Evidentiary Criteria for Biomarker Qualification, developed in collaboration with FDA, NIH, the Critical Path Institute, PhRMA and numerous drug companies.
12/06/2016
 
 
TXT FDA OKs Genentech’s Avastin for Ovarian/Fallopian Tube Cancers [1209 Words] [ Price : $8.95]
FDA approves Genentech’s Avastin (bevacizumab), either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone, for treating patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
12/06/2016
 
 
TXT Former FDA Official Outlines Needed Improvements at Agency [1755 Words] [ Price : $8.95]
A former FDA official calls out the agency over a couple of recent approvals that defy common sense and lack scientific proof that they are safe and effective, and offers seven suggestions on how to improve the agency.
12/06/2016
 
 
TXT ICD Protocol, Implementation Weaknesses: Study [2768 Words] [ Price : $8.95]
Researchers say they found that current ICDs are vulnerable to computer attacks that could compromise patient safety.
12/06/2016
 
 
TXT CGMP Deviations Found in Spain’s Interquim [2674 Words] [ Price : $8.95]
FDA warns Spain’s Interquim about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
12/06/2016
 
 
TXT Comments Extended on Abuse-deterrent Properties for Opioids [110 Words] [ Price : $8.95]
Federal Register Notice: FDA extends the comment period related to its public meeting on “Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products.”
12/05/2016
 
 
TXT CDER New Drugs Director Jenkins to Retire [226 Words] [ Price : $8.95]
After almost 25 years at FDA, CDER Office on New Drugs director John Jenkins announces his retirement.
12/05/2016
 
 
TXT Comments Sought on Device Pediatric Use Information [162 Words] [ Price : $8.95]
Federal Register Notice: FDA seeks comments on an information collection extension request related to a guidance on “Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act.”
12/05/2016
 
 
TXT Guidance on Clin Pharm Labeling for Drugs [1102 Words] [ Price : $8.95]
Federal Register Notice: FDA makes available a guidance entitled “Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products — Content and Format.”
12/05/2016
 
 
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