New
FDA guidance, which is intended to assist applicants in developing the
INDICATIONS AND USAGE section of labeling for human prescription drug and
biological products has been issued.
This
is for drugs that are approved under the accelerated approval regulatory
pathway (hereafter accelerated approval) as defined in section 506(c) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 314,
subpart H, or 21 CFR part 601, subpart E. More specifically, this guidance
focuses on indications for drugs approved via accelerated approval on the basis
of a surrogate endpoint or a clinical endpoint other than survival or irreversible
morbidity. This guidance also addresses labeling considerations for indications
that were approved under accelerated approval and for which clinical benefit
subsequently has been verified and the FDA terminates the conditions of
accelerated approval under 21 CFR 314.560 or 21 CFR 601.46. In addition, this
guidance addresses labeling considerations when the FDA withdraws approval of
an indication that had been approved through the accelerated approval pathway
while other indications for the drug remain approved.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
No comments:
Post a Comment
Pharmaceutical Microbiology Resources