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DLA Piper

January 2017

DLA Piper’s lawyers provide guidance to help support life sciences companies that focus on improving health through the prevention, diagnosis, and treatment of diseases.

The FDA’s approach to laboratory developed tests has been dramatic and complicated. Now, the agency says it will not issue final guidance that would have regulated LDTs as medical “devices” and the laboratories performing them as medical device “manufacturers.”

The 21st Century Cures Act, signed into law by President Barack Obama in December 2016 with broad bipartisan support, will have a meaningful effect on hospitals, behavioral health providers, and many other providers. Understanding its key components will be critical.

Vermont’s statewide test of value-based purchasing is putting into practice the latest CMS ideas about the structure of future healthcare funding.
See our report.

Success in the life sciences industry can depend on a company’s ability to share knowledge and collaborate with strategic partners while protecting its intellectual property – intangibles with enormous value independent of the services of any individual.

Cybersecurity updates to medical devices already in the field can trigger FDA reporting. What do device manufacturers need to know to understand their obligations under Part 806?

Patent protection for methods claims – particularly for medical devices, diagnostics and even drugs – can present thorny enforcement problems. It may all boil down to the key question of “who” – who performs each of the required steps?

HHS issues its final rule to improve public access to information about specified clinical trials involving FDA-regulated products. See our chart setting out the key changes.

In draft guidance on data integrity current Good Manufacturing Practices, FDA warns pharma companies that compliance is a top enforcement focus. What new insight does the draft guidance lend about agency expectations?

The FDA releases a 25-page draft guidance addressing its oversight of certain Next Generation Sequencing technology.

How have recent developments in case law affected the molecular diagnostics industry? And where do we go from here? A look at the latest issues.

About us
DLA Piper is a global law firm with lawyers in more than 30 countries throughout the Americas, Asia Pacific, Europe, Africa, and the Middle East, positioning us to help companies with their legal needs around the world. We achieve this through practical and innovative legal solutions that help our clients succeed, delivering consistent services across our platform of practices and sectors in all matters we undertake. Find out more at www.dlapiper.com.

Learn more
To learn more about DLA Piper, please contact Lisa Haile (Co-Chair, Global Life Sciences Sector and US Life Sciences Sector), Matt Holian (Co-Chair, US Life Sciences Sector), or Rick Mulloy (Co-Chair, US Life Sciences Sector)


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