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With More OTC Drugs On Radar, US FDA Reminds Industry Of Statement Of Identity Requirements

Consumer Self-Care Also Noted In Sodium, Potassium, Phosphorous Labeling Recommendations

Executive Summary

Draft guidances published on statements of OTC drug identity and strength and on labeling of sodium, potassium and phosphorous levels. Recommendations come as agency and drug industry anticipate more OTC remedies becoming available through proposed ACNU rule and streamlined monograph program.

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US FDA’s Proposed ACNU OTC ‘Failure’ Reports Requirement: Asking Too Much, Or Too Little?

Periodic summaries FDA is considering are “most effective method to track and report relevant concerns,” but “failure” as outlined in proposed rule is too broad, says CHPA. Digital care delivery firm Amwell says FDA should ask ACNU OTC marketers for some individual adverse event reports in addition to summaries.

Timers Start Ticking At US FDA In A Month For An Even Dozen OTC Monograph Meeting Requests

CDER Office of Nonprescription Drugs already accepts requests but won’t start responding until FY2023 begins on 1 October, also the start of FDA’s first year meeting with firms developing monograph changes and evaluating submitted proposals under deadlines included in program overhaul Congress authorized in 2020.

US FDA Touts Benefits From Remote Assessments, Manufacturers Feel Burden – Trade Groups

CHPA members’ feedback on RRAs indicate that “time and resources saved by FDA do not translate to time saved by the manufacturer.” CRN suggests FDA “clearly identify the purpose of the RRA in its initial request and limit requested documents to only those directly related to the purpose of the RRA.”


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