Hogan Lovells Publications
HHS announces public meeting on ways to accelerate clinical innovation Health Alert
04 June 2019
Government seeks industry comment on expediting medical product development
Hogan Lovells Publications
U.S. Supreme Court rules judges must decide whether preemption applies, and clarifies when it does Pharmaceuticals and Biotechnology Alert
29 May 2019
Opinion highlights importance of a "clear" record at FDA
Events
Sydney: Join leaders from Hogan Lovells Medical Device team for conversation and cocktails
16 May 2019 | 3:00 PM - 5:00 PM (AEST)
We welcome you to join members of our medical device and health care regulatory team as we discuss how to navigate the shifting regulatory landscape facing medical device firms. From...
Sponsorships and Speaking Engagements
9th Annual Medical Device Supplier Quality Assurance Conference
29-30 April 2019
Dennis Gucciardo addressed the regulatory clarification on risk assessment within the ISO 13485:2016 framework at the 9th Annual Medical Device Supplier Quality Assurance Conference.
Hogan Lovells Publications
New FDA draft guidance on voluntary recalls highlights importance of recall initiation plans Focus on Regulation
25 April 2019
On 23 April, Food and Drug Administration (FDA) issued draft guidance entitled "Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C," which aims to clarify how firms in a...
Hogan Lovells Publications
New OMB review process could impede FDA issuance of guidance documents Medical Device Alert
24 April 2019
Starting on 11 May 2019 there will be an additional layer of government review that may slow down the issuance of certain U.S. Food and Drug Administration (FDA) guidance documents.
Key contacts
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Useful Links
Individualized therapies and the future of drug regulation The emergence of intelligent systems in health care A directory of our U.S. government and agency experienceAwards and recognitions
2019
Band 1 for Healthcare: Pharmaceutical/Medical Products Regulatory in the District of Columbia
Chambers USA
2018
Highly Recommended for FDA Medical Devices
LMG Life Sciences
2018
Regulatory Firm of the Year
LMG Life Sciences Awards
