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April 01, 2002
Proposed funding increases for FDA reflect plans to significantly increase user fees collected from manufacturers under the Presciption Drug User Fee Act.
March 01, 2002
FDA wants manufacturers to revise product labeling and packaging and step up adverse-event monitoring to reduce risky product use.
February 01, 2002
FDA's Center for Drug Evaluation and Research is driving efforts toward creating initiatives to streamline regulatory processes, speed up drug production, and reduce costs.
January 01, 2002
Pharmaceutical companies will face a number of issues and challenges this year that will affect their resources, operations, and the markets they serve.
December 02, 2001
Anthrax contamination has put pharmaceutical quality and supply issues on the front page, along with patent and pricing policies.
November 02, 2001
Threats of bioterrorism generate new reulatory policies to protect the public against biological warfare.
October 02, 2001
FDA may adopt new requirements to enhance the safe use of pharmaceuticals and ensure that all US drugs are available when needed.
September 02, 2001
Providing prescription drug benefits for senior citizens is a pressing issue for Congress, pharmaceutical manufacturers, pharmacies, and ultimately the beneficiaries of proposed plans.
August 02, 2001
The Center for Drug Evaluation and Research is adopting new approaches to how it oversees the development and approval of new drugs and how it ensures the safe use of prescription drugs by the public.
June 02, 2001
FDA's new initiatives for the safe use of prescription drugs try to balance manufacturers' concerns about increased regulations with a low-risk approach to patient safety.