Eye on FDA

NOVEMBER 17, 2020

Because the regulatory oversight of COVID became highly politicized, and after some missteps by FDA, some states have indicated that any federal decision will be reviewed, but that does not seem likely to present much a barrier in terms of timeline, if at all. But first there will be regulatory rites of passage.

Communication

pharmaphorum

JUNE 11, 2021

However, data-intensive, decentralised clinical trials also present a major risk to healthcare participants through cybercrime and data privacy vulnerability. HIPAA in the United States, a regulatory reference, was designed to protect patient privacy but not necessarily data security.

Vaccines

FDA Law Blog: Biosimilars

MAY 26, 2025

While ensuring that a pre-enforcement challenge is properly presented to a court is not a simple task, it can be done, and for those interested, there may be much to challenge. Nevertheless, individuals and organizations could be in receipt of grand jury or HIPAA subpoenas requesting records, or they could be visited by federal agents.

Labelling