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TXT Supply Chain Suspect Product Guidance Out [2808 Words] [ Price : $8.95]
FDA issues a guidance to help trading partners identify a suspect product and notify FDA and other trading partners.
12/08/2016
 
 
TXT FDA Clears Exact Imaging Micro-Ultrasound System [86 Words] [ Price : $8.95]
FDA clears an Exact Imaging 510(k) for its ExactVu micro-ultrasound system for urological procedures.
12/08/2016
 
 
TXT Support for Multi-Region Trial Guidelines [2679 Words] [ Price : $8.95]
Stakeholders voice support for International Conference on Harmonization draft guidelines on multi-region clinical trials and make specific suggestions for changes.
12/08/2016
 
 
TXT Government Wants SCOTUS Biosim Provision Review [2813 Words] [ Price : $8.95]
The acting solicitor general says the Supreme Court should hear appeals by Amgen and Sandoz involving two key related provisions of the Biologics Price Competition and Innovation Act.
12/08/2016
 
 
TXT Mutual Reliance Initiative Expands Drug Inspections [2839 Words] [ Price : $8.95]
FDA associate commissioner Dana Corrigan says FDA is partnering with European Union regulatory authorities to expand drug manufacturing inspections through reliance on each otherís efforts.
12/07/2016
 
 
TXT Praise for Biosim User Fee Agreement [2775 Words] [ Price : $8.95]
Three industry stakeholders praise the agreement reached for reauthorization of the Biosimilars User Fee Act.
12/07/2016
 
 
TXT FDA Moves to Improve Hearing Aid Accessibility [420 Words] [ Price : $8.95]
FDA says it will no longer require medical evaluations and signed waivers before consumers purchase a hearing aid, and it is considering a new OTC approach for the devices to lower cost for consumers.
12/07/2016
 
 
TXT CFSAN Posting Adverse Event Data Files [1136 Words] [ Price : $8.95]
Federal Register Notice: FDA makes available data extracted from adverse event reports from 2004 to the present for food (including food additives, color additives, and dietary supplements) and cosmetics regulated by CFSAN.
12/07/2016
 
 
TXT Trump Team Looking at Non-Medical Person to Lead FDA [442 Words] [ Price : $8.95]
President-elect Donald Trumpís reportedly considers a Silicon Valley venture capital manager to take the helm at FDA.
12/07/2016
 
 
TXT FDA Determines Regulatory Review Period for Merckís Gardasil 9 [60 Words] [ Price : $8.95]
Federal Register Notice: FDA determines the regulatory review period for Merckís Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) for patent extension purposes is 2,662 days.
12/07/2016
 
 
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