US FDA Guidance On Patient Labeling Leaves Unanswered Questions For Combination Products
Final guidance does not address recommendations raised by PhRMA and others about product descriptions and incorporating human outcome factors in instructions for use.
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FDA Draft Guidance Urges Consistency, Plain Language In Combo Product Instructions
A new draft guidance document from the US agency offers nuts-and-bolts guidance on formatting Instructions for Use (IFUs) for drug-device and biologic-device combination product applications.
FDA’s Office Of Generic Drugs Gets New Permanent Director And Oversight Designee
Iilun Murphy, a 15-year agency veteran, takes helm of OGD. Jacqueline Corrigan-Curay to assume oversight of the office and report to CDER director.
DOJ Enforcement: Talking With US FDA Is Not Enough To Get Credit For Self-Disclosure
Remediation of a problem with FDA is one factor the DOJ considers in assessing whether a company gets credit for self-disclosure of misconduct prior to a criminal investigation, but it wants companies to come directly to the department to divulge wrongdoing.