Joanne S. Hawana

Sep 4, 2024 | lexology.com | Joanne S. Hawana |Benjamin M. Zegarelli

Agencies across the federal government continue to grapple with how to respond to the directives in President Biden’s October 2023 executive order on artificial intelligence, including the Food and Drug Administration (FDA) and its parent agency the Department of Health and Human Services (DHHS).

Aug 15, 2024 | lexology.com | Joanne S. Hawana

Many life sciences stakeholders are familiar with “traditional” designation programs operated by the Food and Drug Administration (FDA) in exercising its medical product authorities, such as the orphan drug designation and breakthrough therapy/breakthrough device designation programs.

Aug 12, 2024 | mondaq.com | Benjamin M. Zegarelli |Joanne S. Hawana |Matthew Tikhonovsky

On August 6, the Food and Drug Administration (FDA) and Clinical Trials Transformation Initiative (CTTI) held a joint workshop to explore "Artificial Intelligence in Drug & Biological Product Development." The workshop featured speakers and panelists from the FDA, academia, the industry, and public interest groups, who nearly all agreed that greater regulatory clarity is needed around AI in drug development, as well as greater public awareness of and trust in AI.

May 13, 2024 | mondaq.com | Joanne S. Hawana |Benjamin M. Zegarelli

The Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs) in the Federal Register on May 6, marking a watershed moment in the agency's arduous decade-plus-long journey toward winding down its historical enforcement discretion posture for LDTs. But FDA's crusade is far from over.

May 6, 2024 | natlawreview.com | Christopher Wells |Joanne S. Hawana |Benjamin M. Zegarelli |Dave Thomas

Skip to main content May 06, 2024 Volume XIV, Number 127 Legal Analysis. Expertly Written. Quickly Found. Trending News United States | Data Shows Continued Increase in Nonimmigrant Visas Issued Print Mail Download i Nonimmigrant visa issuance continued to climb in fiscal year 2023, surpassing pre-pandemic totals, according to recently published State Department statistics.