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TXT Respironics Class 1 Recall of Ventilators [87 Words] [ Price : $8.95]
Respironics begins a Class 1 recall of its Esprit V1000 and V200 Ventilators that were installed with third-generation power supplies due to AC power failures.
11/19/2014
 
 
TXT FDA Clears BrainScope’s Ahead 100 Brain Injury Evaluator [97 Words] [ Price : $8.95]
FDA approves a BrainScope Co. de novo classification petition allowing the marketing of its Ahead 100 device that uses a patient’s electroencephalograph to provide an interpretation of the structural condition of the brain after a head injury.
11/19/2014
 
 
TXT Public Docket on First Generic ANDA Submissions [98 Words] [ Price : $8.95]
Federal Register Notice: FDA opens a public docket on its proposed criteria for “first generic” ANDA submissions.
11/19/2014
 
 
TXT Comments Sought on Tobacco Product Studies [36 Words] [ Price : $8.95]
Federal Register Notice: FDA seeks comments on consumer studies on perceptions of modified risk tobacco products.
11/19/2014
 
 
TXT CDER Releases SDTM Validation Rules [65 Words] [ Price : $8.95]
Federal Register Notice: CDER is making available: “Validation Rules for Study Data Tabulation Model (SDTM) Formatted Studies.”
11/19/2014
 
 
TXT Guidance on Vaginal Microbicides for HIV [93 Words] [ Price : $8.95]
Federal Register Notice: FDA is releasing a guidance: Vaginal Microbicides: Development for the Prevention of HIV Infection.
11/19/2014
 
 
TXT FDA Seeks Drug Risk/Benefit Perception Measures [194 Words] [ Price : $8.95]
FDA proposes drug advertising research to give it a pool of measurement tools to evaluate consumer perceptions of risk and benefit information in ads over a variety of platforms.
11/19/2014
 
 
TXT Chemistry Question-based Review MAPP [290 Words] [ Price : $8.95]
CDER’s Office of Pharmaceutical Science issues a MAPP on using a question-based review template.
11/19/2014
 
 
TXT Look at FDA Role in Drug Competition: Report [310 Words] [ Price : $8.95]
A Matrix Global Advisors report says more attention should be paid to the ways in which FDA helps and hurts drug price competition.
11/19/2014
 
 
TXT New Requirements for Info on ClinicalTrials.gov [258 Words] [ Price : $8.95]
The National Institutes of Health proposes new rules on registration and summary results information from some clinical trials for ClinicalTrials.gov.
11/19/2014
 
 
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