In an environment of increasingly complex and rapidly changing FDA regulations and aggressive enforcement actions, we help life sciences companies remove obstacles in their path and quickly get over the hurdles.
In recent years, we’ve watched FDA struggle with regulating new technologies, such as regenerative medicine, medical mobile apps, and even social media. And we know FDA continues to scrutinize advertising and promotional activities, especially those that appear to promote off-label use.
We’re also seeing a significant increase in foreign manufacturing facility inspections, Import Alerts, and related Warning Letters
We stay on top of these trends so that we can help clients proactively identify and avoid problems that could disrupt their business. We advise our clients on issues from product development and clinical research, to commercialization and compliance programs. We know first-hand how and why FDA takes enforcement actions and how best to respond, whether it be a voluntary recall or a response to a 483 or Warning Letter, or even a seizure or injunction.
And while we provide advice on a full range of technologies, we have particular experience in cutting-edge technologies, such as stem cell therapies and other cellular and tissue-based products, pharmacogenomics, wireless and mobile medical devices, companion diagnostics, and new biotech products.
Our FDA group works closely with our other Life Sciences practice groups to help clients comply with a panoply of complex laws and regulations carrying both civil and criminal penalties, including those enforced by the FTC, SEC, PTO, USDA, and DEA.
Who we work with
- Biotech, medical device, and pharmaceutical companies
- Hospitals and health care institutions
- Foreign manufacturers of FDA-regulated products
- Leading universities and academic medical centers
- Manufacturers and importers of food and food-related products
- FDA's Biggest New Policies of 2014: Midyear Report
Law360 | July 28, 2014
Washington, DC, Health Care and Life Sciences partner Areta Kupchyk is quoted in this forward-looking feature story on new rules and guidance from the U.S. Food and Drug Administration making waves for drug and device makers.
- Personalized Medicine Changes the Rules of the Play (Personoitu Laaketiede Muuttaa Pelisaantoja)
Mediuutiset (Finland) | March 21, 2014
In this Finnish health care publication, Boston Patents counsel Leena Karttunen Contarino provides commentary on how the FDA defines personalized medicine and about the FDA’s attempts to handle personalized medicine drugs and devices in an integrated process.
- Life Sciences Regulation and Legislation to Watch in 2014
Law360 | January 1, 2014
Washington, DC, Health Services and Life Sciences partner Areta Kupchyk discusses FDA’s involvement in laboratory-developed testing, momentum on biosimilars, and possible further guidance on developing tailored medications.