LawFlash/Client Alert | FDA and Healthcare LawFlash
FDA and Healthcare Practice

On May 18, 2010, the U.S. Department of Health and Human Services, Office of Inspector General (HHS OIG) issued revised guidance on independence and objectivity standards related to independent review organizations (IROs) that p... more

LawFlash/Client Alert | FDA and Healthcare LawFlash
FDA and Healthcare Practice

As part of President Obama's Open Government Initiative, the U.S. Food and Drug Administration (FDA or the Agency) launched its own Transparency Initiative in June 2009. FDA commissioner Dr. Margaret Hamburg created and charged... more

LawFlash/Client Alert | FDA and Healthcare LawFlash
FDA and Healthcare Practice

On February 9, the U.S. Food and Drug Administration (FDA) announced a broad new initiative to reduce unnecessary patient exposure to radiation from medical imaging procedures. The announcement follows the FDA's recent investig... more

LawFlash/Client Alert | Foreign Corrupt Practices Act LawFlash
Litigation Practice

On November 12, the Justice Department's Assistant Attorney General for the Criminal Division, Lanny Breuer, issued a stern warning to the life sciences industry and its executives. As the country wrestles with the challenges o... more

LawFlash/Client Alert | FDA and Healthcare LawFlash
FDA and Healthcare Practice

FDA issued draft guidance on the presentation of risk information in prescription drug and device promotion on May 26. The draft guidance is long and dense, and describes factors FDA considers when evaluating the compliance of ... more

Outside Publication | Article
M. Elizabeth Bierman, Michele Buenafe

Presentation | Speech
Kathleen Sanzo

LawFlash/Client Alert | FDA and Healthcare LawFlash
FDA and Healthcare Practice

The Food and Drug Administration (FDA) is proposing to actively regulate a new class of computer- and software-based products that electronically collect, transfer, and store data from medical devices such as glucose meters and ... more

Newsletter | Article
Barbara Melby

In today’s increasingly competitive global economy, medical device companies are continually seeking ways to drive down production costs while at the same time improve quality and accelerate time-to market. Outsourcing the manu... more