Tag Archives: off-label drug information

House Panel Approves Off-Label Communication, OTC Monograph User Fee, Good Samaritan Health Professionals Bills

The House Energy and Commerce Health Subcommittee voted to approve the following health policy bills on January 18, 2017: H.R. 2026, the Pharmaceutical Information Exchange (PIE) Act. This bill would create a safe harbor that would allow drug and medical device companies to share certain health care economic or scientific information with payers, formularies, and … Continue Reading

Upcoming FDA Public Meeting on Speech and Medical Products

As a reminder, the Food and Drug Administration (FDA) is holding a two-day public meeting on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”  The meeting comes at a time where recent litigation has raised hot-button issues regarding the relationship between FDA, off-label use of drugs … Continue Reading

FDA Seeks Comments to Updated Guidance on Informed Consent in Clinical Trials

This post was written by Jennifer Pike and Vicki Morris. Earlier this summer, the Food and Drug Administration (FDA) issued a draft 42-page “Informed Consent Information Sheet” that provides guidance for institutional review boards (IRBs), clinical investigators, and clinical trial sponsors on complying with the Agency’s informed consent regulations. Once finalized, the draft guidance will … Continue Reading
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