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...
Blog Post
The reflection paper and extrapolation
Blog Post
On November 9, FDA Commissioner Scott Gottlieb, M.D., announced that the agency launched new inspection protocols for aseptic processing of sterile drugs to be used by FDA investigators...
Blog Post
In a big win for the Food and Drug Administration (FDA), the D.C. Circuit of the United States Court of Appeals reinforced FDA’s position on what constitutes a “meaningful...
Blog Post
On Tuesday, FDA announced the entry of a consent decree of permanent injunction against Keystone Laboratories, Inc. of Memphis, Tennessee for manufacturing OTC hair care and skin care...
Blog Post
Earlier today, FDA Commissioner Scott Gottlieb, M.D., made publicly available for the first time FDA’s internal policy (MAPP 5014.1) for how drug manufacturing facilities are...
Blog Post
On July 18, FDA Commissioner Scott Gottlieb, M.D., announced the release of FDA’s Biosimilars Action Plan (BAP), saying it would help enable a path to competition for biologics from...
Blog Post
On 27 July 2018, the European trade association representing the medical technology industries, MedTech Europe, issued a position paper in which the association requests the European...
