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FDA finalizes guidance on device shortage reporting rules
The FDA responded in 2023 by proposing a list of product codes that would be subject to the reporting requirements. At the time, the FDA suggested adding “506J Device List” and “Additional ...
clinicaltrialsarena on MSN3d
FDA protocol deviation guidance could go further
The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.
Medical Design and Outsourcing8d
FDA’s Tarver pushes for mandatory medical device shortage reporting
The FDA is urging Congress to implement mandatory medical device shortage reporting to address growing vulnerabilities in the ...
JD Supra15d
FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for Nonprescription Use
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...
The American Journal of Managed Care1d
FDA Quietly Removes Draft Guidance on Diversity in Clinical Trials Following Executive Order on DEI
The FDA removed previously issued draft guidance on diversity in clinical trials from its website without public notice or ...
FDA pauses updates on foodborne outbreak probes as health agencies regroup on communications
The Trump administration's "short pause" on communications, expected to end on Feb. 1, has affected FDA updates on food ...
STAT2d
How to protect HHS, FDA, NIH, and other health agencies from political interference
When politicians subordinate scientific institutions to electoral interests, they undermine immediate public health efforts ...
JD Supra12d
FDA Issues Detailed Guidance for Biopharma Industry on What Information to Provide to FDA About Use of AI Models
On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use ...
Bird Flu Concerns Prompt New FDA Guidance on Raw Pet Food Safety
MONDAY, Jan. 27, 2025 (HealthDay News) -- Reports of cats becoming seriously ill or dying after consuming raw pet food or ...
US FDA Drops Web Pages on Improving Clinical Trial Diversity
CHICAGO (Reuters) - The U.S. Food and Drug Administration has pulled draft guidance from its website requiring companies to ...
Healio3d
Decentralized clinical trials: FDA guidance and the ‘new modus operandi’
The COVID-19 pandemic forced investigators conducting clinical trials to use decentralized elements, such as telehealth, to ...