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May 02, 2008
The US Food and Drug Administration announced its Pharmaceutical GMPs for the 21st Century initiative six years ago. This article reports on the outcome of a recent workshop on this topic and the action plan set forth.
April 10, 2008
In an ongoing effort to secure the safety of prescription drugs, the US Food and Drug Administration has released its draft five-year plan under the Prescription Drug User Fee Act (PDUFA).
Senator Chuck Grassley (R-IA) sent a letter to Amgen (Thousand Oaks, CA) last week asking the company to account for the high rebates it has given to certain physician groups who bought Aranesp.
April 03, 2008
Filing risk and mitigation strategies is now a requirement for manufacturers of new drugs and biologics.
March 13, 2008
Much to the surprise of most close observers of the Food and Drug Administration, Janet Woodcock agreed last month to resume control of the Center for Drug Evaluation and Research.
March 06, 2008
With another potential "made-in-China" crisis looming over the recall of heparin, critics and the media seem to be waiting in line to take another jab at the US Food and Drug Administration.
March 02, 2008
There are significant differences between the United States and European Union requirements for the annual review of records related to the manufacturing and control for pharmaceutical products and active pharmaceutical ingredients.
January 02, 2008
Pharmaceutical manufacturers often avoid putting new excipients in their formulations for fear of more regulatory oversight. IPEC has a solution.
QbD, PAT, design space, what's it all about? This seems to be a common industry response to FDA's directional push.
December 28, 2007
The US Food and Drug Administration's joint panel of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee voted against recommending approval of the over-the-counter use of Merck & Co.'s “Mevacor” (lovastatin) 20 mg.