CHPA Looks For FDA Reform Legislation To Deliver Monograph Changes In 2016
This article was originally published in The Tan Sheet
CHPA chief Scott Melville is optimistic for OTC monograph reform progress in 2016. In an interview about CHPA's 2016 priorities, Melville also said state and local environmental regulations that touch OTC drugs will garner attention.
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During the inaugural negotiating session for renewal of PDUFA, which covers OTC switch and other nonprescription product NDAs, FDA says among its goals are “enhancements to the review processes.” The five-hour session included the ground rules for the talks and FDA and industry representatives also laid out their general wants and needs.
CHPA is optimistic 2015 is the year “common sense” will restore OTC eligibility for health spending accounts. Speaking on the group’s priorities, President and CEO Scott Melville said CHPA will work to improve the OTC monograph system and to curb cough medicine abuse.
FDA’s OTC Monograph User Fees Are Existential Threat To Small Contract Manufacturers, Cosmetics Brands
OMUFA reauthorization should include small business considerations for the US FDA’s OTC Monograph Drug User Fee Program, which established in 2020 a ‘one-size-fits-all’ facility and monograph order request user fee system which could lead to more contract manufacturer exits, a manufacturing bottleneck for OTC cosmetic products, and fewer product choices, says IBA.