Regulatory Oversight, Final Guidance, Prescription Drugs

FDA Finalizes Guidance on Communications Regarding Unapproved Uses of Medical Products

McCarter & English, LLP on 3/6/2025

In January 2025, the US Food and Drug Administration (FDA) finalized its 2023 revised draft guidance Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

FDA Announces Guidance for DSCSA Process to Request a Waiver, Exception, or Exemption

Quarles & Brady LLP on 8/23/2023

On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more

FDA Publishes Informed Consent Final Guidance for Drug and Medical Device Clinical Investigations

Nelson Mullins Riley & Scarborough LLP on 8/16/2023

The U.S. Food and Drug Administration (FDA or the Agency) has issued the final guidance document, “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” (Final Guidance). The...more

FDA Issues Final Guidance on PDUFA Waivers, Reductions, and Refunds

Wilson Sonsini Goodrich & Rosati on 10/21/2019

The Prescription Drug User Fee Act of 2017 (PDUFA VI) authorizes the U.S. Food and Drug Administration (FDA) to assess fees (PDUFA fees) when applicants submit new drug applications (NDAs). PDUFA fees are substantial. For...more

FDA Finalizes Data Integrity Guidance, With Some Noteworthy Changes

Hogan Lovells on 12/13/2018

Earlier yesterday, FDA published the final guidance “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” which updates April 2016 draft guidance that covers the design, operation, and monitoring of systems...more

Regulatory Oversight › Final Guidance › Prescription Drugs

FDA Finalizes Guidance on Communications Regarding Unapproved Uses of Medical Products

FDA Announces Guidance for DSCSA Process to Request a Waiver, Exception, or Exemption

FDA Publishes Informed Consent Final Guidance for Drug and Medical Device Clinical Investigations

FDA Issues Final Guidance on PDUFA Waivers, Reductions, and Refunds

FDA Finalizes Data Integrity Guidance, With Some Noteworthy Changes

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