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Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.
October 02, 2007
Expanded access to drugs for seniors has increased demand and focused attention on costs.
September 25, 2007
House and Senate leaders finally agreed on compromise legislation to renew prescription user fees, just a few days before the funding program was set to expire.
September 02, 2007
User-fee legislation will require more testing and data disclosure to prevent unsafe drug use.
August 02, 2007
FDA's long-awaited GMPs for supplements appear as food and drug safety concerns override lingering opposition.
July 02, 2007
The US Food and Drug Administration has pursued many new initiatives since 1977. The agency began accepting abbreviated applications for generic versions of drugs, collected user fees to support drug review, launched the Critical Path Initiative to encourage innovation, and worked to harmonize its regulatory standards with those of Europe and Japan. New challenges such as AIDS and bioterrorism have affected regulatory policy in recent years. The author reviews FDA's changes in policy and philosophy during the past 30 years.
June 02, 2007
Product characterization and production challenges are key issues in developing a pathway for biosimilar therapies.