Hogan Lovells Publications
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 ...
Hogan Lovells Publications
On 20 February 2019 the U.S. Food and Drug Administration (FDA) released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle...
Blog Post
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
On Tuesday, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance, "Principles of Premarket Pathways for Combination Products," with high-level...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
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
Following the recent landmark decision of the South African Constitutional Court, in which the private and personal use of cannabis was decriminalised, together with the publication of...
Blog Post
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...
Hogan Lovells Publications
On 4 January, China's National People's Congress (NPC) released draft amendments to the Chinese Patent Law, proposing expanded and enhanced protections that may provide real benefits to...
Blog Post
Earlier today, FDA published its finalized Data Integrity Guidance. The Final Guidance is entitled “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” and...
Blog Post
Today, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological...
Blog Post
On 7 December, China announced its newly implemented pilot centralized drug procurement program will cut prices for certain off-patent generic drugs by up to 96%. Under the program, China...
