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
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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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.
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.
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.”