Drugs

Strong Stakeholder Support for PDUFA 8

Pharmaceutical Research and Manufacturers of America (PhRMA) says it strongly supports the draft PDUFA 8 commitment letter. The PhRMA comment says PDUFA 8 will help ensure the long-term sustainability of FDA’s human drug review program and strengthen agency capabilities by:

enhancing the efficiency of the drug review process to accelerate the development and availability of new medicines to patients while providing scientific and regulatory predictability;
strengthening communication and effective engagement between FDA and sponsors throughout the product lifecycle;
transitioning successful pilot programs into sustainable regulatory practice to support continued innovation in clinical development; and
strengthening financial stewardship to sustain operational efficiency and infrastructure that supports timely, high-quality review.

In its response, the Biotechnology Innovation Organization (BIO) says it “strongly supports the proposed PDUFA 8 agreement and urges FDA to transmit the package to Congress without alteration.” BIO says the agreement reflects an important continued commitment to a strong, predictable, efficient, and science-based human drug review program, while introducing meaningful enhancements across premarket review, regulatory science, drug safety, manufacturing, resource management, and information technology.

Hoping to have additional changes made to the commitment package, the National Organization for Rare Disorders (NORD) says it supports timely reauthorization of PDUFA while emphasizing that speed must be paired with scientific rigor, meaningful patient engagement, transparency, and sufficient resources to sustain a capable and responsive FDA. NORD says its comments reflect four priorities: (1) advancing the Rare Disease Innovation Hub, (2) strengthening the patient voice in drug development and regulatory decision-making, (3) supporting innovation for rare diseases, and (4) ensuring a well-resourced and agile FDA of the future. NORD recommends a number of changes it says would meet its four priorities.

CDRH on Hiring Spree After Losing 22% of Workforce

CDRH is accelerating hiring after losing about 22% of its workforce over the past year and a half, including up to 30% of its clinical reviewers and significant numbers of artificial intelligence and digital health specialists. CDRH drector Michelle Tarver disclosed the staffing losses 10/21 at AdvaMed's

Bipartisan Policy Center Comment on Generative AI Devices

The Bipartisan Policy Center (BPC) says it supports FDA’s goal of a risk-based, least-burdensome approach that gives patients timely access to safe and effective generative artificial intelligence (AI) device functions. Responding to an FDA discussion paper on the subject, BPC makes these key points: * several approaches in

Improve FDA Myelodysplastic Syndromes Guidance

Researchers from Johns Hopkins and the University of Miami say myelodysplastic syndromes (MDS) therapeutic development is challenged by the syndromes’ biological diversity and regulatory risk. Writing in Blood Advances, the researchers say MDS is “ideal for FDA to implement flexible, biology-informed regulatory pathways. Establishing such frameworks in MDS could

Court Rejects FDA HCT/P Designation

A Georgia federal court has determined that FDA misread its own regulations in determining that a MiMedx wound care powder product was not a human cell, tissue, or cellular- or tissue-based product (HCT/P) because it was not minimally manipulated. Attorneys Vanessa Hampton and Alan Minsk (Arnall Golden Gregory)

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CDRH on Hiring Spree After Losing 22% of Workforce

Bipartisan Policy Center Comment on Generative AI Devices

Improve FDA Myelodysplastic Syndromes Guidance

Court Rejects FDA HCT/P Designation