The Food and Drug Administration (FDA) recently announced that it had identified “significant data integrity and study conduct concerns” with bioequivalence studies conducted by the India-based contract research organization...more
On April 11, 2025, the National Security Division (NSD) of the Department of Justice issued a press release (Press Release) that outlines its approach to implementing and enforcing the DOJ’s recent final rule on “Preventing...more
As privacy laws continue to proliferate in the U.S. and globally, there is one trend that companies, especially those operating in the health and pharmaceutical sectors, can no longer overlook. This is the trend towards data...more
Overview -
On February 28, 2024, the Biden administration released an Executive Order that would restrict “countries of concern” from accessing Americans’ sensitive personal data, including “genomic data, biometric data,...more