The U.S. FDA is well known for encouraging industry to meet with the agency “early and often” for complex premarket filings, but the Combination Products Coalition (CPC) says a recent draft guidance seems to offer the exception. The group said the December 2019 FDA guidance for feedback on combination product applications “seems to generally discourage” the use of the combination product agreement meeting (CPAM). It added that the complexity of some combination products suggests that such a meeting may well be crucial to an efficient application process.
Rated the No. 1 most prepared country in the world to tackle an epidemic, the U.S. could see its preparedness put to the test as it responds to the growing COVID-19 outbreak. While the administration is pointing to that rating from a recent global survey to calm fears about the risk in the U.S., the coronavirus emergency is spotlighting cracks in the nation’s preparedness.
LONDON – Brexit finally becomes a reality at midnight central European time on Jan. 31, but for the life sciences industry uncertainty continues, as the U.K. enters an 11-month transition phase during which the terms of its future relationship with the EU must be negotiated.
Whether large or small, or based in the U.S. or abroad, life sciences companies are an increasingly attractive target for shareholder suits. The number of securities fraud class action suits filed in the U.S. in 2019 across all industries totaled 404, just one more than the 403 cases filed in 2018 and down from the peak of 412 in 2017, according to a new Dechert LLP report.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking input from industry stakeholders on a proposal to increase its fees to cover projected deficits this year. The proposal outlines three options.
Time will tell whether what the Trump administration is calling a “historic” and “landmark” trade agreement with China will better enable drug and device companies to more fairly compete in the Chinese market without having to sacrifice their intellectual property (IP) and technology.
BOGOTA, Colombia – The Latin American med-tech sector is moving steadily toward 3D printing solutions to speed up production and cut costs in specific sub-sectors, such as orthotic devices. A case in point is Prothesia, of Monterrey, Mexico.
Time will tell whether what the Trump administration is calling a “historic” and “landmark” trade agreement with China will better enable drug and device companies to more fairly compete in the Chinese market without having to sacrifice their intellectual property (IP) and technology.
The FDA's revised draft guidance for clinical decision support (CDS) systems was intended to fix several glaring holes in the first draft, but multiple stakeholders argued that the second draft contradicts the related provisions of the 21st Century Cures Act when it comes to CDS systems that purport to drive or guide clinical decision making.
Researchers are hopeful that within three to five years the first once-a-month oral contraceptive could reach human testing. They achieved an early step on that path with the publication of research testing the long-lasting drug delivery device from Watertown, Mass.-based startup Lyndra Therapeutics Inc. in the Dec. 4, 2019, issue of Science Translational Medicine.
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