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Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.
October 02, 2004
FDA and industry discuss proposals for regulating combination diagnostics, medical devices, and pharmacogenomic-based drug products.
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.