NonStandard Stability Protocols May Receive FDA Special Assessment Review
Executive Summary
General sponsor inquiries regarding the adequacy of a protocol should not be addressed under FDA's special protocol assessment provisions, the agency said in a Feb. 8 draft guidance on special protocol assessment.
You may also be interested in...
Special protocol assessment final guidance
FDA's 1special protocol assessment guidance, issued May 17, makes "minor changes" to the draft "to make the document more clear." The draft guidance was released in February 2000 (2"The Pink Sheet" Feb. 14, 2000, p. 18). The House Commerce/Oversight Subcommittee is examining special protocol assessments in connection with its investigation into ImClone's BLA for Erbitux (3"The Pink Sheet" March 25, p. 20)...
Special protocol assessment final guidance
FDA's 1special protocol assessment guidance, issued May 17, makes "minor changes" to the draft "to make the document more clear." The draft guidance was released in February 2000 (2"The Pink Sheet" Feb. 14, 2000, p. 18). The House Commerce/Oversight Subcommittee is examining special protocol assessments in connection with its investigation into ImClone's BLA for Erbitux (3"The Pink Sheet" March 25, p. 20)...
FDA Refuse-To-File Policy Records Requested Under House ImClone Probe
The House Commerce/Oversight Subcommittee is asking FDA to provide records relating to its policy on refuse-to-file letters, as part of its broadening investigation into ImClone