April 14, 2023: NCHR comment on the CMS plan to fully implement the authorities provided by Congress in the Inflation Reduction Act (Pub. L. 117-169) to lower the costs of prescription drugs for beneficiaries through drug price negotiations.
Read More »Author: Caroline Bradford
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 »FDA Accelerated Approval Pathway: Controversies and Reform
Recent controversies of drugs granted accelerated approval have raised important questions about the evidence needed to determine whether the benefits outweigh the risks in the short-term or the long-term, and what can be done to improve the pathway.
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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