Blog Post
Will FDA be forced to implement a drug importation program?
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.”...
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Hogan Lovells Publications
With the statutory deadline approaching, FDA issues a proposed sunscreens rule Focus On Regulation
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
Pharmaceutical Sector remains under Scrutiny of EU Competition Enforcers
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
Would you like an extra application with that? FDA mulls requiring dual applications for combination products Focus On Regulation
On Tuesday, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance, "Principles of Premarket Pathways for Combination Products," with high-level...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
FDA to consider patent listing, therapeutic equivalence, and other Orange Book issues; agency will issue draft guidance documents, seek public comment Focus On Regulation
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
The EMA has published a Concept paper for a Guideline for the development of medicinal products containing allergens to treat rare allergic diseases
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...
