FDA Law Blog

JUNE 12, 2022

established by statute and case law. If there were a failure to comply, “subsequent claims relating to the affected devices could be rendered ‘false or fraudulent’ because the government would not have paid the claims for those affected devices but for the defendant’s conduct.”. This fraudulent inducement theory is well?established

Manufacturing 52

Manufacturing Contract Data Management Statute 52

InHouseOps

JULY 2, 2021

We only share information with internal authorization as our investigations are confidential under our governing statute,” said a securities regulator in North America. “We The definitions ranged from better data mapping and improved remote access to increased automation and effective data management.

Technology 52

Technology Education Malfeasance eDiscovery 52

FDA Law Blog

OCTOBER 10, 2022

Consistent with the 2019 draft guidance, the final guidance also includes textbooks, approved drug or medical device labeling, and government agency recommendations as other permissible types of medical information. Criterion 4: The fourth criterion seeks to ensure that Non-Device CDS does not supplant an HCP’s independent clinical judgment.

Drafting 52

Drafting Statute Data Management Manufacturing 52