The US FDA’s decision to finalize a promotional guidance defining a new class of permitted claims that are “consistent with the label” is probably disappointing to some advocates for broad readings of the First Amendment as it applies to drug company communications.
Learning To Love The “CFL”: US FDA’s New Communication Policy
Final guidance on communication “consistent with the label” is noteworthy for how closely it follows Obama-era draft. That may be a surprising twist given the background of the Trump-era FDA Commissioner and HHS Secretary – but on balance is probably the best possible approach for maintaining the current FDA approval climate.
More from Marketing & Advertising
More from Compliance
• By
Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.
• By
Pharma executives and investors are waiting with bated breath to find out if President Trump will include drugs in a new round of tariffs to be announced on 2 April.
• By
Results from a single-arm study cannot support representations on overall survival, progression-free survival and disease control rate for the cancer drug, the Office of Prescription Drug Promotion said in another “untitled” letter implicating the agency’s CFL guidance.