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TXT CDRH ‘Customer Satisfaction’ Survey Score Slips [1253 Words] [ Price : $8.95]
An ongoing CDRH customer service satisfaction survey score slips from 88% of respondents in 2015 reporting that they had received satisfactory responses or information in their Center interactions to a 84% satisfactory rating as of this month.
01/18/2017
 
 
TXT FDA Finds CGMP Violations at Horizon Pharmaceuticals [2832 Words] [ Price : $8.95]
FDA’s Florida District Office warns Horizon Pharmaceuticals about CGMP violations for finished pharmaceuticals.
01/17/2017
 
 
TXT Latest FDA Warning Letters [637 Words] [ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Horizon Pharmaceuticals, Northern Health Products, Pharm D Solutions, Sato Yakuhin Kogyo, and Suzhou Pharmaceutical Technology.
01/17/2017
 
 
TXT Medical Evidence Generation Collaborative Integrates Info [2795 Words] [ Price : $8.95]
FDA associate deputy commissioner Rachel Sherman and departing commissioner Robert Califf describe efforts to build an evidence generation collaborative.
01/17/2017
 
 
TXT Suzhou Pharmaceutical CGMP Violations [2801 Words] [ Price : $8.95]
FDA warns Suzhou Pharmaceutical about significant deviations from CGMP for APIs.
01/17/2017
 
 
TXT Medical Device Cybersecurity Guidance Outlined [2971 Words] [ Price : $8.95]
Ropes & Gray attorneys summarize provisions in an FDA final guidance on post-market cybersecurity risk prevention and mitigation.
01/17/2017
 
 
TXT MDR Violations Led CDRH Warning Letters [2648 Words] [ Price : $8.95]
Covington & Burling reviews issues raised in CDRH 2016 Warning Letters on medical device reporting.
01/17/2017
 
 
TXT SCOTUS to Hear Amgen/Sandoz Appeals [2773 Words] [ Price : $8.95]
The Supreme Court agrees to hear appeals from Sandoz and Amgen on key provisions of the Biologics Price Competition and Innovation Act.
01/17/2017
 
 
TXT FDA Draft Guide on Medical Product Communications [1670 Words] [ Price : $8.95]
FDA releases a new draft guidance on “Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers” dealing with how the agency evaluates firms’ medical product communications that present information that is not contained in, but may still be consistent with, the FDA-required labeling.
01/17/2017
 
 
TXT Trump Candidate for FDA Post Deletes His Tweets [1381 Words] [ Price : $8.95]
One of president-elect Donald Trump’s candidates for leading FDA deletes his Twitter posts, presumably to block the public from learning his thoughts and criticisms about the agency and other areas.
01/17/2017
 
 
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