US FDA Portal Open To Receive OTC Monograph Meeting Requests
Submitting other OTC monograph program communications through CDER's NextGen Portal, including proposals to add formulations or indications to a monograph, will have to wait.
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US FDA Postpones Advisory Panel Meeting On Oral Phenylephrine GRASE
Change noted without elaboration in update to FDA announcement on Nonprescription Drugs Advisory Committee meeting. CHPA also notes change, saying it’s best for Industry and for consumers.
US FDA Catches Up On Monograph Petitions: Denies Antiseptic TFM Requests Made In 2001
Agency’s recent responses denying three petitions filed in 2001 by US industry trade groups and in 2002 by pharmaceutical ingredient and chemicals firm explain the changes requested can be proposed in “OTC monograph order requests” pathway established in program overhaul.
US Consumer Health Industry In 2023: Monograph Results, Switch Hopes On OTC Drug Sector Radar
OTC drug and dietary supplement industry trade group executives discuss questions on potential market and regulatory developments affecting their members’ businesses. HBW Insight reports on OTC drug sector’s outlook for the FDA potentially publishing a final rule to expand switch opportunities as well as its anticipation of marketplace results from monograph program overhaul.