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TXT FDA Communication Guidances Draw Comments [2996 Words] [ Price : $8.95]
Stakeholders provide comments on and seek changes in FDA draft guidances on communication of regulated product information that is consistent with the product’s approved labeling.
04/20/2017
 
 
TXT Cardiac Insight Gains Clearance for ECG Sensor [97 Words] [ Price : $8.95]
FDA clears a Cardiac Insight 510(k) for its wearable electrocardiogram sensor, Cardea Solo.
04/20/2017
 
 
TXT Pfizer Gets IV Saline Solution Probe Subpoenas [2752 Words] [ Price : $8.95]
Pfizer says it has received grand jury subpoenas relating to a Justice Department probe of three companies that are the sole source for intravenous saline solution in the U.S.
04/20/2017
 
 
TXT Target Product Profile Benefits Education Needed: CDER [2699 Words] [ Price : $8.95]
Three CDER staffers say that using a target product profile can speed regulatory review times.
04/19/2017
 
 
TXT Aurobindo India Plant Hit With Form-483 [129 Words] [ Price : $8.95]
FDA concludes a 4/10-18 inspection at Aurobindo Pharma’s formulations manufacturing facility in Hyderabad, India that resulted in a six-item Form-483.
04/19/2017
 
 
TXT Government Says SCOTUS Shouldn’t Hear Decosters’ Appeal [2867 Words] [ Price : $8.95]
Attorney Jennifer Thomas says the federal government opposes an appeal by the Decoster brothers of their three-month jail term for responsible corporate officer violations under the FFDCA.
04/19/2017
 
 
TXT Egalet Files for 2 Additional Oxayda Dosage Strengths [156 Words] [ Price : $8.95]
Egalet Corp. files a prior approval supplement for Oxaydo (oxycodone HCl, USP) tablets that seeks to market 10 mg and 15 mg dosage strengths for use in treating moderate to severe pain.
04/19/2017
 
 
TXT FDA Clears Life Spine’s Plateau-C Ti Cervical Spacer [66 Words] [ Price : $8.95]
FDA clears a Life Spine 510(k) for the Plateau-C Ti Cervical Spacer System.
04/19/2017
 
 
TXT Violations at ZS Pharma Listed [2739 Words] [ Price : $8.95]
FDA releases the FDA-483 with six observations issued after an inspection at ZS Pharma.
04/19/2017
 
 
TXT HELP Committee Pegs Vote on Gottlieb FDA Nomination [280 Words] [ Price : $8.95]
The Senate Health, Education, Labor & Pension Committee plans a 4/26 vote on Scott Gottlieb to be the next FDA commissioner.
04/19/2017
 
 
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