FDA issues draft guidance on expanded access to investigational drugs

FDA grants Fast Track designation to 225Ac-FL-020 radiopharmaceutical for mCRPC

FDA granted Fast Track designation for Ac-FL-020, a radiopharmaceutical which targets prostate-specific membrane antigen for the treatment of metastatic castration-resistant prostate cancer.xxx:more

July 12, 2024

Vol.50 No.28

Judiciary News Analysis

Supreme Court removes “Chevron deference,” threatening drug regulation, health coverage, delivery of cancer care

The Supreme Court last week upended one of the underpinnings of administrative law by weakening the authority of federal health agencies to rely on technical expertise as they regulate medical products, issue coverage decisions, and respond to public health crises.

July 05, 2024

Vol.50 No.27

By Matthew Bin Han Ong

Conversation with The Cancer Letter

Georgetown’s Zachary Baron on the post-Chevron era: We need guardrails about when agency expertise should be cast aside

The Supreme Court struck down the Chevron doctrine, removing one of the foundational principles of administrative law and upending the way federal agencies rely on technical subject-matter expertise. What comes next?

July 05, 2024

Vol.50 No.27

By Matthew Bin Han Ong

Drugs & Targets

FDA grants Fast Track designation to Syncromune Inc. for drug-device combo for solid tumors in mCRPC

FDA granted Fast Track designation to Syncromune Inc., a clinical-stage biopharmaceutical company, for SYNC-T SV-102 therapy, Syncromune’s lead candidate for the treatment of patients with metastatic castrate-resistant prostate cancer.

July 05, 2024

Vol.50 No.27

White House

At White House forum, Bertagnolli, Califf, Wegrzyn call for greater innovation in clinical trials

Leaders of three health agencies presented new initiatives focused on patient-centered research, diversity in clinical trial enrollment, and innovation in clinical research.

June 28, 2024

Vol.50 No.26

By McKenzie Prillaman

Clinical Roundup

FDA guidance provides new details on diversity action plans for clinical studies

FDA issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product sponsors in submitting diversity action plans to support certain clinical studies.

June 28, 2024

Vol.50 No.26

FDA issues draft guidance on expanded access to investigational drugs

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FDA grants Fast Track designation to 225Ac-FL-020 radiopharmaceutical for mCRPC

Supreme Court removes “Chevron deference,” threatening drug regulation, health coverage, delivery of cancer care

Georgetown’s Zachary Baron on the post-Chevron era: We need guardrails about when agency expertise should be cast aside

FDA grants Fast Track designation to Syncromune Inc. for drug-device combo for solid tumors in mCRPC

At White House forum, Bertagnolli, Califf, Wegrzyn call for greater innovation in clinical trials

FDA guidance provides new details on diversity action plans for clinical studies

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