je.st

Home › citizen

Tag: citizen

FDA Denies Amgen's Citizen Petition Regarding Biosimilar Applicant Requirements

2015-04-03 07:01:53| Biotech - Topix.net

Late last week, the U.S. Food and Drug Agency dismissed a citizen petition filed by Amgen, Inc. asking the agency to require that biosimilar applicants provide the reference product sponsor with a copy of their application and information on their manufacturing processes. At issue is the meaning of the term " shall " and whether the information-sharing and advance-notice provisions of the Biologics Price Competition and Innovation Act that a biosimilar applicant "shall providea copy of the application submitted [to FDA]and such other information that describes process or processes used to manufacture the biological product" is a mandatory requirement or an optional action for the biosimilar applicant.

Tags: requirements citizen applicant petition

Citizen pile driving documents

2015-03-24 18:43:46| PortlandOnline

attachment to May 2014 NRB meeting related to pile driving noise from Pearl residents PDF Document, 9,270kbCategory: Pile Driving Noise Study

Tags: documents driving citizen pile

US citizen charged in Sydney with bribery over bank contract

2015-03-18 10:18:19| IT Services - Topix.net

A U.S. citizen who was recently a senior executive at the Commonwealth Bank of Australia pleaded not guilty in a Sydney court Wednesday to charges that he accepted bribes to award a contract to a U.S. information technology firm. Keith Robert Hunter , 61, formerly of San Francisco, and his alleged accomplice - another Sydney-based American who has not been named - were allegedly paid $2.19 million for awarding a bank contract to ServiceMesh without a tender, according to court documents.

Tags: bank contract charged sydney

US citizen charged in Sydney with bribery over bank contract

2015-03-18 04:19:24| Automakers - Topix.net

Police say a U.S. citizen formerly employed by a major Australian bank has been charged in Sydney with bribery and more than $1.5 million in suspected corrupt payments have been frozen as part of a joint FBI-Australian police investigation. State police said in a statement Wednesday that officers arrested the 61-year-old American at a Sydney apartment on Tuesday and charged him with two counts of bribery.

Tags: bank contract charged sydney