February 29, 2016. The FDA should make it clear that the agency will not approve medical products for all populations if the sponsor has not tested the product for safety and effectiveness on all major demographic subgroups and provided meaningful subgroup analyses.
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Patient, Consumer, and Public Health Coalition Testimony at 2016 FDA Public Meeting on Demographic Subgroup Data
February 29, 2016. The FDA should make it clear that the agency will not approve medical products for all populations if meaningful subgroup analysis for safety and effectiveness were not conducted for major demographic groups.
Read More »NCHR Testimony at FDA on Allergy Products
January 21, 2016. Allergies can be a life-and-death situation. Treatment options for food allergies could save lives, significantly improve quality of life for many families, and reduce the number of severe reactions from occurring. We must require that clinical trials study all of the necessary variables to help families make informed treatment choices.
Read More »Comments of the Patient, Consumer, and Public Health Coalition on Drug Interactions with Hormonal Contraceptives
December 15, 2015. As members of the Patient, Consumer, and Public Health Coalition, we support FDA’s effort to better characterize drug interactions with hormonal contraceptives since reliable and accurate information is necessary to ensure women’s health. In particular, we recommend clinical evaluation of drug interactions for all drugs that are likely to be used in women of reproductive age and that have the potential to cause birth defects, in addition to improving the quality and usefulness of information in FDA-approved labeling.
Read More »NCHR Testimony at FDA on Codeine Use in Children
December 10, 2015. NCHR strongly urges the FDA to require labeling that states that codeine is contraindicated for cough and pain in children less than 12 years of age.
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