Caroline Bradford

Dr. Diana Zuckerman’s Testimony at the FDA Advisory Committee Meeting on Microbiology Devices on HBV Assays

September 7, 2023: We testified that FDA’s plan to reclassify hepatitis B (HBV) assays from high risk (Class III) to moderate risk (Class II) would mean lack of evidence of accuracy. Why do that when there are already accurate assays available? Lowering the standards would harm patients by resulting in inappropriate treatments.

NCHR Comments on the FDA Proposed Guidance Regarding the Registration and Listing of Cosmetic Product Facilities and Products

September 7, 2023: NCHR provided comments on the FDA guidance regarding the registration and listing of cosmetic product facilities and products required in the Modernization of Cosmetics Regulation Act of 2022. We support these requirements and provide recommendations to improve the guidance.

NCHR Comments on The E6(R3) Guideline for Good Clinical Practice and International Council for Harmonisation Draft Guidance

September 5, 2023: We support the overall goals of the Good Clinical Practices International Council Harmonisation guidance. But we recommend strengthening diversity criteria and providing objective trial oversight while leveraging stakeholder engagement committees to improve study quality and participant safety.

Do Antidepressants Increase Suicide Attempts? Do They Have Other Risks?

Research shows that antidepressants can increase suicide risk in people. When depressed people become somewhat less depressed, they feel less hopeless and more able to attempt suicide. But there is evidence that antidepressants may also increase the risk of suicide for other reasons, such as akathisia. Other risks from antidepressants include blood clots and birth defects. Antidepressants also have a “placebo effect” that makes the drugs seem more effective than they really are. Safe and effective alternatives include cognitive behavioral therapy and physical activity.

Everything You Need To Know to Choose Safe Cosmetic Products

Cosmetics, including shampoo and other products we all use, will cost U.S. consumers $92 billion this year. They contain various chemicals, often including harmful substances like parabens and phthalates. These products can also harm the environment and pose greater risks to salon workers. His article helps consumers read labels, reduce exposures to unsafe ingredients, and choose eco-friendly cosmetics for safety.