On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
Hogan Lovells Comments on the FDA's "Draft Guidance on Responding to Unsolicited Requests"
As our FDA group follows these issues closely on behalf of the industry, we filed a Comment on this draft guidance encouraging the agency to reconsider and clarify certain elements of the Draft Guidance, specifically with respect to:
- “Public” responses at meetings held between manufacturers and health care practioners,
- The materials that should accompany a response, and
- The role of toll-free customer service numbers in prompting requests for off-label information.
FDA's final position on these issues may have a significant impact on how the industry engages in non-promotional exchange of scientific and medical information in response to unsolicited questions from healthcare professionals. We will provide an update when FDA finalizes its guidance.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017