Blog Post
23 July 2019
Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.”...
Hogan Lovells Publications
13 March 2019
On 26 February, the U.S. Food and Drug Administration (FDA) published the proposed rule, "Sunscreen Drug Products for Over-the-Counter Human Use," which describes the conditions under which ...
Blog Post
18 February 2019
On 28 January 2019, the European Commission published its Report to the Council and Parliament regarding "Competition enforcement in the pharmaceutical sector (2009-2017)" ("Report")....
Hogan Lovells Publications
08 February 2019
On Tuesday, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance, "Principles of Premarket Pathways for Combination Products," with high-level...
Hogan Lovells Publications
04 February 2019
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will take to ensure that the Orange Book (FDA's publication of Approved Drug...
Blog Post
23 January 2019
On 13 December 2018, the EMA published a “Concept paper on a Guideline for allergen products development in moderate to low-sized study populations”. Four EMA guidelines...
