Drugs

FDA, NIH Working to Cut Animal Testing

FDA and the National Institutes of Health (NIH) are “working together extremely closely” in the effort to reduce animal testing for drugs. That’s the report of NIH deputy director for program coordination, planning, and strategic initiatives Nicole Kleinstreuer, who said, “I think what we’re seeing is an unprecedented level of cooperation and collaboration between agencies right now.” In an online Fierce Biotech interview, Kleinstreuer said that one of her previous efforts in government involved directing the congressionally-mandated interagency coordinating committee on the validation of alternative testing methods.

Earlier this year, the report says, CDER released new guidance specifying that drug approval applicants are welcome to submit data from new approach methodologies, even if the method hasn’t previously been approved by FDA to replace animals.

Kleinstreuer says NIH awarded $87 million in contracts a year ago to launch the Standardized Organoid Modeling Center at the NIH’s Frederick National Laboratory for Cancer Research. She said the plan is to support regulatory bodies such as FDA, as well as clinicians and scientists in academia and industry, in developing standardized organoid models for preclinical testing of potential new drugs, thus reducing reliance on animal modeling.

Having received death threats from activists who want her to move more quickly to abolish animal testing. Kleinstreuer told Fierce she knows the effort to reduce animal testing is a long road, and it’s important to resist the temptation to drive through the changes too quickly.

“It’s certainly, you know, easier to try and claim that we should just turn everything off overnight,” Kleinstreuer said. “But, unfortunately, that would not be sustainable. We would suffer severe backlash, both from a scientific and a patient advocacy perspective. What we need to do is do the hard work to make a change that will last, and that will further advance the most protective and predictive and rigorous science.”

Integrating Randomized Trials and Real-World Data

Biostatisticians from FDA and several universities say interest in integrating randomized clinical trials (RCTs) with real-world data (RWD) continues to grow as stakeholders seek evidence that is both internally valid and relevant to clinical practice. Writing in an open-source article in Clinical Pharmacology & Therapeutics, the researchers say,

TAP Pilot Has 159 Enrolled Devices

FDA says that as of 10/7, there are 159 medical devices enrolled in the Total Product Life Cycle Advisory Program (TAP) pilot. An online update also says that on 7/1, TAP expanded to accept enrollment requests across all Offices of Health Technologies for Breakthrough-designated and Safer Technologies

Analysis Sees More Depth, Specificity in FDA Drug Inspections

A review of 42,192 observations from 8,663 inspections conducted between 2008 and 2026, as shown on the FDA inspection dashboard, found that 2026 does not represent a wholesale shift in FDA inspection priorities. Rather, according to regulatory consultant Jeffrey Palmer, writing in an online post, it reflects intensified

FDA AI Office Faces Test Turning Policy Into Practical Rules

FDA’s decision to establish its new Office of Innovation and Clinical Trial Modernization (OICTM) and form dedicated divisions for artificial intelligence (AI) and real-world evidence (RWE) analytics (see earlier story) could provide drug developers with a clearer regulatory pathway for emerging technologies, but the agency now faces the

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Integrating Randomized Trials and Real-World Data

TAP Pilot Has 159 Enrolled Devices

Analysis Sees More Depth, Specificity in FDA Drug Inspections

FDA AI Office Faces Test Turning Policy Into Practical Rules