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Life Sciences, Biotechnology & Nanotechnology
Smart & Biggar
On November 20, 2019, the Federal Court (FC) issued its reconsideration decision on the quantum of damages owed by Apotex for its infringement of eight Eli Lilly process...
Norton Rose Fulbright Canada LLP
Health Canada received an ATI request for information on Fortekor.
DeHeng Law Offices
DeHeng Law Offices
DeHeng Law Offices
DeHeng Law Offices
European Union
DLA Piper
On 7 January 2020, the EU Medical Device Coordination Group published new guidance to help manufacturers fulfil all relevant cybersecurity requirements in Annex I ...
A decree was recently published modifying several provisions of the Health Law Regulations addressing the approval of biologic drugs.
ELIG Gürkaynak Attorneys-at-Law
In May, 2019, the Agency had announced the Draft Regulation on Sales, Advertising and Promotion of Medical Devices, expected to replace the Regulation on Sales, Advertising and Promotion of Medical Devices, ...
United States
Sheppard Mullin Richter & Hampton
The core responsibilities of the FDA are to promote public health by reviewing and assuring the safety, effectiveness, quality, and security of drugs, vaccines, medical devices, and several other products.
Womble Bond Dickinson
If you believe there are important reasons to test your DNA, then ask your doctor to run the tests and explain the results.
The FDA "prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28).
Womble Bond Dickinson
So you want to know how much Neanderthal is in your genes.
Hogan Lovells
As part of its continuing efforts to advance biologics competition, the U.S. Food and Drug Administration (FDA) on February 3 published a 10-page Q&A draft guidance...
Ropes & Gray LLP
The ongoing public health crises of opioid addiction and youth vaping undoubtedly captured significant attention and enforcement resources in 2019
Continuing progress on the initiatives announced in its Biosimilars Action Plan in July 2018 (see our prior post here), the Food and Drug Administration (FDA)
As discussed in an earlier blog post, the process for reauthorizing human medical product user fee programs at the Food and Drug Administration (FDA)...
Duane Morris LLP
Beginning January 1, 2020, California, Illinois, and Nevada became the first states to ban the sale of cosmetic products and ingredients that have been tested on animals.
Mayer Brown
This market trends article examines recent trends in life sciences.
Reed Smith
If asbestos litigation reminds of the 100 Years War, and the Bone Screw litigation recalls (for us) the winning side of the Franco-Prussian War
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