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Regulation/Legislation (Health)

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Regulation

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Latest From Health & Regulation

Prevacid 24HR First OTC PPI With Skin Reaction Warning

Lansoprazole along with other OTC and Rx PPI ingredients were linked to a potential risk of acute generalized exanthematous pustulosis FDA in 2019 found a trend in adverse event reports.

FDA Drug Safety

Proposed OTC Switch Rule Anticipates Digital World

FDA’s “Additional Condition for Nonprescription Use” proposal is all about information which won’t be printed on DFLs but will be integral to whether some switch proposals’ approval. But agency doesn’t explicitly exclude switch sponsors from assigning delivery of ACNU information to staff in stores or in online chats.

Prescription To OTC Switch Retail

Dual Rx/OTC Status In US ‘Additional Condition’ Switch Proposal: Necessary Or Questionable?

OTC drug development and marketing consultants discuss FDA allowing simultaneous Rx and OTC sales of same drug formulation with the same indication and about opportunities for follow-on generic equivalents of switches approved as additional condition for nonprescription use OTCs.

FDA Policy
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Legislation

Set Alert for Legislation {Health}

Latest From Health & Legislation

Over the Counter 29 June 2022: OTC Birth Control In The Wake Of The US Supreme Court Decision With Victoria Nichols

In this episode, HBW Insight speaks to Victoria Nichols, project director of Free the Pill, a campaign supporting increased OTC oral contraceptive access in the US. In the wake of the Supreme Court’s decision to overturn Roe v. Wade on 24 June, Nichols discusses the importance of advocating for OTC birth control, the limited availability of OTC oral contraceptives in the US, and the current legislation being introduced that would help ensure OTC birth control is covered by insurance. 

United States OTC Drugs

US FDA Likely To Embrace In-Person, Remote Combo For Facility Inspections Going Forward

System likely will evolve as post-pandemic world unfolds, but adds to list of agency programs expecting to continue using virtual platforms once in-person activities are no longer restricted by COVID-19.

FDA Regulation

US House Appropriators Seek Data On Fragrance Allergens In Cosmetics, ‘Balance’ In Sunscreen Regs

The House Appropriations Committee asks the US Food and Drug Administration to provide a report to Congress in two years on the resources it would need to develop a database for fragrance allergens used in cosmetics. The committee’s report accompanying FY2023 FDA funding legislation also touches on OTC sunscreen regulation, PFAS in cosmetics, skin-lightening ingredients, and more.

United States Legislation
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