OR WAIT null SECS
February 02, 2007
"Quality by design" (QbD) and "quality risk management" at long last seem to be moving from the buzzword stage to becoming important influences on drug development and manufacturing. A series of quality standards issued by the International Conference on Harmonization (ICH) is encouraging the adoption of common quality-based drug manufacturing approaches designed to reach the "desired state" of drug manufacturing (i.e., more efficient, agile, flexible operations that can reliably produce high-quality drug products with less regulatory oversight). These developments reflect increased pressure to make pharmaceutical manufacturing more efficient and less wasteful and to encourage regulators in all regions to focus on the most critical issues affecting product quality and patient safety.
January 25, 2007
The US Food and Drug Administration announced the creation of the Office of the Chief Medical Officer as well as two important staff changes at the agency.
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.
November 30, 2006
Basel, Switzerland (Nov. 17)-Novartis plans to submit additional information to the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency on manufacturing issues to support the approval of its antifungal drug "Mycograb." The CHMP issued a negative recommendation for the drug.
November 03, 2006
Liverpool, UK (Oct. 20)-Novartis Vaccines and Diagnostics Limited is recovering two lots totaling 500,000 doses of its ?Fluvirin? influenza virus vaccine after reports that the product had been received from distributor Cardinal Health Care in either a frozen state or below the required storage temperature range of 35?46 degrees F.
October 05, 2006
Missouri City, TX (Oct. 3)-The US District Court for the Western District of Texas denied the Department of Justice?s motion to alter its Aug. 30 decision that the US Food and Drug Administration does not have the ability to regulate drug compounding.
September 28, 2006
The Bulk Pharmaceuticals Task Force (BPTF), an affiliate organization of the Synthetic Organic Chemical Manufacturers Association (SOCMA, Washington, DC) submitted a citizen petition to the US Food and Drug Administration (Washington, DC) requesting the agency to increase inspections of drug manufacturing facilities located outside of the United States.
September 01, 2006
Companies must create a risk-based framework for developing and manufacturing drugs, and acquire the scientific knowledge and technological skills to create more complex products.
December 02, 2005
CDER is reorganizing staffs and developing new policies to encourage industry adoption of quality production systems.
December 01, 2005
OTC Eye-Drop Maker Signs Consent Decree