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September 02, 2004
FDA is re-engineering the CMC review process for innovator and generic drugs and backing risk-based ICH quality standards.
August 02, 2004
FDA's latest proposal focuses on electronic health systems for filing drug labeling information and facility and product data.
July 02, 2004
Decisions to accelerate the approval of AIDS combination drugs, reject the over-the-counter status for the morning-after pill, and limit support for stem cell research are hot political topics.
June 02, 2004
Congress is proposing legislation to legalize drug importing and holding hearings about emerging options.
May 02, 2004
New technologies, along with changes in FDA oversight, may provide a critical path to make more new drugs available more quickly to patients.
April 02, 2004
FDA relies on e-chips to thwart bogus products, and drops paper pedigrees and unit-of-use packaging.
March 02, 2004
Healthcare coverage and costs remain prime concerns for FDA as the number of uninsured Americans continues to grow.
February 02, 2004
FDA expands electronic data submission programs to improve regulatory operations and ensure appropriate and safe drug use.
January 02, 2004
The new Medicare bill affects pricing and coverage, revises payment formula, and clarifies generic patent issues.
December 02, 2003
FDA initiatives aim to spur the development of more-affordable treatments and ensure safe product use.