May 9, 2023: NCHR testified on the proposed first-in-class prescription-to-nonprescription switch of OPill (norgestrel) tablet, a progestin-only oral contraceptive pill (POP), and expressed concerns that the data demonstrated that a substantial minority of consumers did not understand written information about how to use the pill safely if they were not instructed by their physician.
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Public Comment of Dr. Diana Zuckerman, President National Center for Health Research At the FDA Advisory Committee meeting on Rexulti for Alzheimer’s patients April 14, 2023
April 14, 2023: Rexulti is already FDA approved as an atypical antipsychotic and FDA held an Advisory Committee meeting in April 2023 to consider approving it for agitation in dementia patients, many of whom are in nursing homes. We expressed concerns about Rexulti’s well-known risks of death for dementia patients. Why isn’t FDA more concerned about safety?
Read More »NCHR Comments on CPSC Proposed Rulemaking on Safety Standards for Non-full-size (NFS) Baby cribs.
April 5, 2023: NCHR supports the additional standards to improve the safety of non-full-size cribs by regulating cords and straps that form a loop and the addition of language to prevent exemptions for cribs intended for playing. However, we also recommend revision to the proposal exempting certain products from including a mattress.
Read More »NCHR addresses proposed changes to acne medicine iPLEDGE program
March 29, 2023: NCHR testimony at an FDA advisory committee recommends changes to the iPLEDGE REMS (risk reduction) program for patients taking the acne medication isotretinoin, which causes birth defects. We recommend eliminating unnecessary barriers for women who are unable to become pregnant and strengthening contraceptive requirements for adolescents.
Read More »NCHR Comments on FDA Guidance for Lead Levels in Food for Babies and Young Children
March 27, 2023: NCHR comments on the new FDA standards for lead in food for babies and young children. Standards must be implemented as soon as possible and should be enforced.
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