The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on...06 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Hogan Lovells Comments on the FDA's "Draft Guidance on Responding to Unsolicited Requests"
As our FDA group follows these issues closely on behalf of the industry, we filed a Comment on this draft guidance encouraging the agency to reconsider and clarify certain elements of the Draft Guidance, specifically with respect to: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.
On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory...03 January 2017
On 8 December 2016, the European Medicines Agency (“EMA”) organised a workshop in collaboration with the European Commission to gather the views and proposals from stakeholders...03 January 2017