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Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.
December 08, 2006
Washington, DC (Dec. 7)-One of the last acts of outgoing Senate majority leader Bill Frist (R-Tenn) was to push through confirmation of Andrew von Eschenbach as the official head of the Food and Drug Administration.
December 02, 2006
Brand-name manufacturers seek to protect their products.
November 02, 2006
FDA must monitor a growing number of facilities and complex drugs despite "resource challenges."
October 02, 2006
A recent analysis found that 9000 marketed drugs are not in FDA's National Drug Code Directory.
September 12, 2006
Washington, DC (Sept. 12)-The Office of New Drug Quality Assessment (ONDQA) in the Center for Drug Evaluation and Research (CDER) has approved one new drug application (NDA) under its CMC Pilot Program and has two more applications are under review. The pilot was established last year to provide an opportunity for FDA and industry to explore strategies for including Quality by Design (QbD) principles and process analytical technology approaches in regulatory submissions, explained ONDQA deputy director Chi-wan Chen at the PDA-FDA Joint Regulatory Conference here
September 02, 2006
Partnerships launched 63 research projects that may translate into nine or 10 new drugs by 2010.