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Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.
October 02, 2002
FDA is set to revise CGMPs to encourage new manufacturing technologies and develop improved agency policies to ensure drug quality and safety.
September 02, 2002
Congress debates legislation for a Medicare drug benefit while the industry expresses concerns about import control, drug counterfeiting, and patent rights.
August 02, 2002
In response to increasing concern about drug safety, FDA has implemented several administrative and policy changes, inclduing the new Office of Pharmacoepidemiology and Statistical Science and a renewed focus on risk assessment.
July 02, 2002
To fund expanded FDA operations designed to streamline drug development and approval, FDA and industry representatives have negotiated the Prescription Drug User Fee Act III.
June 01, 2002
FDA cites manufacturing difficulties as a main contributing factor to recent drug shortages, which mainly involve injectibles and vaccines.
May 01, 2002
ICH continues its efforts to establish universal drug development standards and testing as pharmaceutical manufacturers press for additional FDA guidance on specifications.