On January 18, 2017, the FDA released draft revised Guidance for Industry (GFI) #187, “Regulation of Intentionally Altered Genomic DNA in Animals,” and requested public comment regarding the regulation of animals with intentionally altered genomic DNA.
21st Century Cures Act PASSES Senate 94-5 . More than $192 million in lobbying expenses have been spent on the 21st Century Cures Act and other legislative priorities by 58 pharmaceutical companies, 24 device companies and 26 biotech companies, according to a Kaiser Health News analysis of lobbying data compiled by the Center for Responsive Politics.
All eyes are on the 21st Century Cures Act this week, a bipartisan bill that would reform the current standards and appropriations for biomedical research, provide $1.75 billion annually for the National Institutes of Health (NIH) and $110 million for the Food and Drug Administration (FDA). This bill is one of the most-lobbied health care bills in recent history, with nearly three lobbyists working for its passage or defeat for every lawmaker on Capitol Hill.
This bill amends the Federal Food, Drug, and Cosmetic Act to add Zika virus disease to the list of tropical diseases under the priority review voucher program, which awards a voucher to the sponsor of a new drug or biological product that is approved to prevent or treat a tropical disease.