On May 29, 2024, the U.S. Food and Drug Administration (“FDA”) released draft guidance titled Platform Technology Designation Program for Drug Development. The draft guidance describes the process for requesting and receiving...more
America’s response to the COVID-19 pandemic will require widespread coordination between the public and private sectors. There is a pressing need for more testing kits and test sites, new treatment and isolation facilities,...more
The State Department is initiating a public process to consider the implications of Access and Benefit-Sharing (ABS) regimes for global health and biomedical research. The Federal Register Notice announcing this initiative...more
6/19/2019
/ DNA ,
Genetic Materials ,
Healthcare ,
Influenza ,
Life Sciences ,
Medical Research ,
Public Health ,
Public Meetings ,
The Nagoya Protocol ,
United ,
United Nations ,
US Department of State ,
Vaccinations ,
World Health Organization
A clash over access to and use of genetic sequence data (GSD) is currently brewing on several international fronts. To date, GSD has been routinely deposited in open-source databases such as GenBank of the National Center for...more
Two years ago today, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits from their Utilization to the Convention on Biological Diversity (“Protocol”) entered into international...more
10/13/2016
/ Biotechnology ,
Brazil ,
Due Diligence ,
EU ,
Genetic Materials ,
Germany ,
India ,
Inventions ,
Mexico ,
Natural Resources ,
Patent Applications ,
Patents ,
Pharmaceutical Industry ,
Popular ,
R&D ,
Recordkeeping Requirements ,
Regulatory Oversight ,
Scientific Research ,
South Africa ,
Switzerland ,
The Nagoya Protocol ,
UK