The U.S. FDA’s remote regulatory assessment (RRA) program, the subject of a guidance the agency finalized in June 2025, is proving to be one of the trickier bits of navigation for makers of devices, drugs and biologics. RRAs were on tap at the 2025 enforcement conference held by the Food and Drug Law Institute, but the session seemed to suggest that industry may not be fully prepared for how the agency will conduct these reviews, but also what it will do with the results.

After a more than 13-year period of stability with Janet Woodcock as the head of CDER, with Patrizia Cavazzoni taking charge during the next four years of former U.S. President Joe Biden’s tenure, the FDA division has had no fewer than five different people in charge throughout 2025. Up to bat now as acting director is Tracy Beth Høeg, a physician and epidemiologist who co-authored a paper in 2022 with CBER Director Vinay Prasad, FDA Commissioner Marty Makary and others demonstrating that COVID-19 boosters and college vaccine mandates were harmful to young men due to myocarditis risks.

Individual liberty and choice vs. wider public health became one predictable hinge upon which swung the often-acerbic debates at the CDC’s Advisory Committee for Immunization Practices (ACIP) meeting, which took up – again – the matter of hepatitis B virus (HBV) vaccine scheduling, a day after the panel voted not to vote on such guidance.

Natera Inc. completed the acquisition of Foresight Diagnostics Inc. in a deal structured as $275 million up front plus contingent payments of up to $175 million based on achieving certain milestones for revenue and reimbursement coverage. The companies expect to close the transaction in the second quarter of 2026.

Freenome Holdings Inc. reported it is going public via a special purpose acquisition company. The company said it expects to raise $330 million, which it plans to use for the 2026 launch of its blood-based screening tests for multiple cancers. Backed by an affiliate of Perceptive Advisors - Perceptive Capital Solutions Corp. (PCSP) – and joined by RA Capital, the arrangement includes a commitment of $240 million in equity investments plus about $90 million more held by the SPAC’s trust fund. Other notable investors, including ADAR1 Capital, Bain Capital Life Sciences, and Farallon Capital Management have signed on to participate in the deal.

The U.S. FDA’s recent switch toward more routine use of generalist field investigators might be seen in some quarters as an attempt to do more with less, but a session on the topic at the Food and Drug Law Institute’s annual enforcement conference in Washington seems to suggest that this reversal of historic practice presents at least as many problems as solutions for industry.

Disorganization resulting from last-minute changes to voting questions involving new recommendations for hepatitis B virus vaccines created a moment of déjà vu Dec. 4 when the CDC’s Advisory Committee for Immunization Practices (ACIP) voted 6-3 to once again delay its votes on whether the current recommended birth dose should be pushed back.

One of the sessions at this year’s Food and Drug Law Institute’s enforcement conference dealt with the use of AI for FDA compliance activities, but the question of AI legislation also arose. The problem with AI legislation, said Nathan Brown of Akin Gump, is how to manage the details of any legislation, which presents enough drag that federally preemptive legislation stands a faint chance of passage anytime soon.

The U.S. FDA granted accelerated approval for the Biologics License Application for Axogen Inc.'s Avance, an acellular nerve allograft that serves as a scaffold for nerve regrowth, for treatment of patients with sensory, mixed and motor peripheral nerve discontinuities. The company expects Avance to be commercially available in the second quarter of 2026.

Roche AG received regulatory clearance from the U.S. and European authorities for a new diagnostic test that detects Bordetella infections, including whooping cough, as cases surge globally. The point-of-care test, which delivers PCR-accurate results in just 15 minutes, will help health care providers to quickly identify infections and act to prevent severe complications, onward transmission and deaths.