Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.
Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.
Analysis
Registered Content
12 April 2018
Preparing for advisory panel meetings
Hogan Lovells Publications
20 September 2017
On September 1, 2017, the Food and Drug Administration (FDA or the Agency) released a final guidance document discussing the procedures for Medical Device Advisory Committee meetings (or,...
Hogan Lovells Publications
03 October 2016
FDA's Expedited Access Program (EAP) provides a process aimed at increasing efficiency and smoothing the path to market for medical devices that address unmet medical needs associated with...
Hogan Lovells Publications
26 September 2016
On September 16, 2016, the Department of Health and Human Services (HHS) issued a final rule to expand the availability of information about applicable clinical trials provided via...
Hogan Lovells Publications
03 August 2016
As part of a series of efforts1 by the U.S. Food and Drug Administration (FDA) to "think outside the box" when it comes to the evidence required to support regulatory decision-making, on...
Hogan Lovells Publications
22 May 2015
On May 18, 2015, the Food and Drug Administration (FDA) released a draft guidance document, Adaptive Designs for Medical Device Clinical Studies, discussing considerations related to the...
Hogan Lovells Publications
22 May 2015
On May 13, 2015, the Food and Drug Administration (FDA or the Agency) released a draft guidance document, Patient Preference Information – Submission, Review in PMAs, HDE Applications, and...
Hogan Lovells Publications
24 April 2015
On April 21, 2015, the Food and Drug Administration (FDA) released a draft guidance document, Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States,...
Hogan Lovells Publications
10 April 2015
On April 1, 2015 the Food and Drug Administration (FDA) released a draft guidance document discussing procedures for Medical Device Advisory Committee meetings, excluding the Medical...
