Article: New leaders at FDA could slow device approvals; A clinical trial executive says resignation of a review center head appears to indicate a desire for increased caution.(BUSINESS)

Article: FDA publishes final guidance on voluntary third-party ...
The Food Institute Report;  February 2, 2009 ;     700+ words ... ... it certifies meet applicable FDA requirements and other certification ... TERMAN BODE MATZ PC. Background FDA is aware that a growing number of food companies require their suppliers to obtain ... security, and quality. Both FDA's Food Protection Plan and ...

Article: FDA, SEC link up on false statements to public.
Warning Letter Bulletin;  March 8, 2004 ;     700+ words ... ... protect the public health, and FDA employees will not be expected ... statements by publicly held, FDA-regulated companies." But FDA employees will now have a centralized ... they come to believe that a company may have made a false or misleading ...

Article: FDA issues draft guidance on committee members' financial ...
Adverse Event Reporting News;  November 5, 2007 ;     700+ words ...FDA has released a draft guidance to help advisory committee members and FDA staff "to understand and implement statutory requirements and FDA policy regarding public availability of information about financial interests and waivers granted by ...

Article: The FDA indicts itself.(AS WE SEE IT)(United States. Food ...
Life Extension;  July 1, 2008 ;     700+ words ... ... Americans have needlessly suffered and died because of FDA incompetence. and the FDA now admits its own incompetence! These tens of millions ... than boasting that every flaw we identified about the FDA is now a documented reality, I instead view it as ...

Transcript: FDA EFFORTS TO ASSURE THE SAFETY OF THE DRUG ...
Congressional Testimony;  February 13, 2007 ;     700+ words ... ... but hadn't told the FDA. The company claimed that there were ... fraud investigation, the company turned over records the FDA- with most of the text ... nothing. In October 2003, FDA received records from the company that raised further concerns ...

Article: FDA NEWS DIGEST, SEPT. 17
US Fed News Service, Including US State News;  September 17, 2007 ;     700+ words ... ... BREAST CANCER RISK IN POSTMENOPAUSAL WOMEN FDA has approved Evista (raloxifene hydrochloride ... who have osteoporosis. http://www.fda.gov/bbs/topics/NEWS/2007/NEW01698 ... IF ADHD DRUGS POSE POSSIBLE HEART RISKS FDA and the Agency for Healthcare Research and ...

Article: FDA NEWS DIGEST, NOV. 6
US Fed News Service, Including US State News;  November 6, 2006 ;     700+ words ... ... affected 21 states and sickened 183 people. FDA says illness cases peaked in late September ... circulation. - Press release: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01504 ... html - Food safety tips: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01503 ...