Drug Labeling Rule Returns To OMB
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA's physician labeling rule has been resubmitted to the White House Office of Management & Budget
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Physician Labeling Final Rule Targeted For Release In May
FDA expects to release the physician labeling final rule by the end of May, according to HHS' semi-annual "unified agenda" published in the May 16 Federal Register
Physician Labeling Final Rule Targeted For Release In May
FDA expects to release the physician labeling final rule by the end of May, according to HHS' semi-annual "unified agenda" published in the May 16 Federal Register
Physician Labeling Rule Will Get Four "Companion" Guidances From FDA
Guidances will discuss labeling format, adverse reactions, clinical studies and warnings, FDA's Behrman says. Structured product labeling will roll out this fall and should be fully populated by October 2006, she says.
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