May

FDA ad hoc committee meets to discuss criminal investigation of Upjohn

PDAC meeting: Halcion is judged to be safe and effective (0.25- and 0.125-mg doses)

June

FDA reviews safety on the basis of data in the new database

• new database numbers judged to be valid

• Halcion judged to be safe

July

United Kingdom announces intention to revoke licenses for Halcion

Public Citizen submits final petition to remove FDA approval

December

FDA investigation of Upjohn terminated

1993

 

June

United Kingdom revokes licenses for Halcion

1994

 

April

FDA medical officer review: labeling and packaging changes

FDA commissioner requests formation of an FDA task force on Halcion to examine criminal misconduct, scientific questions, and regulatory concerns

1996

 

May

FDA task force on Halcion issues its report

1997

 

April

FDA contracts Institute of Medicine to assess data quality

August

FDA denies Public Citizen petition to remove approval of Halcion

November

IOM report Halcion: An Independent Assessment of Safety and Efficacy Data



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