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New Draft Guidance On Quality Agreements: No Passing The Buck On CGMPs

2013-09-12 09:44:31| drugdiscoveryonline News Articles

Last month, FDA released a draft guidance document entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” The guidance addresses relationships between the entities that introduce a drug into interstate commerce (the “Owner”) and third parties that perform some or all of the manufacturing operations for the product (the “Contracted Facilities”). The guidance describes how Owners and Contracted Facilities can use Quality Agreements to define responsibilities associated with manufacturing activities in a manner that is consistent with regulatory requirements. By Cathy L. Burgess, Donald E. Segal and Guillermo Cuevas, Alston & Bird LLP

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AASHTO Urges Amtrak and States to Complete Passenger Rail Agreements

2013-09-12 06:00:00| Industrial Newsroom - All News for Today

Paying mind to federally mandated October 16 deadline, AASHTO urged Amtrak and state DOTs to complete negotiations over capital investments and operations along state-supported intercity passenger rail corridors. AASHTO recognized commitment states have made in negotiating to complete agreements with Amtrak to sustain service, and AASHTO executive director Bud Wright added that "significant disruption in travel and mobility" will be seen if said agreements are not in place soon. This story is related to the following:Trade Associations

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U.S., Canada Spectrum Agreements Expand Wireless Capacity

2013-08-31 07:46:07| Wireless - Topix.net

A recently released set of radio frequency spectrum agreements between the United States and Canada will expand broadband wireless capabilities along the two nations' shared border.

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House Members Call for Strong SPS Provisions in Trade Agreements

2013-08-26 18:44:00| National Hog Farmer

By P. Scott Shearer, Bockorny Group, Washington, DC Congressman Tim Griffin (R-AR) and Ron Kind (D-WI) along with 76 other Congressmen wrote U.S. Trade Representative Michael Froman on the significant potential for American agricultural exports to expand in the Asia-Pacific and European trade regions. The Congressmen emphasized the need for USTR and the administration to negotiate the strongest possible sanitary and phytosanitary (SPS) measures in both the Trans-Pacific Partnership (TPP) and the Transatlantic Trade and Investment Partnership (TTIP) currently under negotiation. read more

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