The U.S. Food and Drug Administration is announcing a public hearing to obtain input on the Over-The-Counter (OTC) Drug Review. FDA would like input on how to improve the current OTC Monograph Process for reviewing certain nonprescription drugs. This public hearing is being held to obtain information and comments from the public on the strengths and weaknesses of the current OTC Monograph Process, the feasibility of potential modifications the Agency has identified, and ideas about other modifications or alternatives to this process.
March 25-26, 2014
9:00 a.m. to 4:00 p.m.
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (Great Room)
Silver Spring, Maryland 20993
Registration to Attend the Workshop:
Register to attend or provide oral testimony at the meeting by submitting electronic requests to CDEROTCMONOGRAPH@fda.hhs.gov by March 12, 2014. Written or electronic comments to the docket has been extended until July 31, 2014.
- Federal Register Notice
- Agenda (PDF - 36KB)
- Meeting Summary (PDF - 35KB)
- Transcript: Tuesday, March 25, 2014 (PDF - 1.3MB)
- Transcript: Wednesday, March 26, 2014 (PDF - 531KB)
- Lodging Information
- R. William Soller, PhD: Evergreen the OTC Review (PDF - 1.2MB)
- CHPA presentation (PDF - 853KB)
W. Greg Collier, PhD: US OTC Monograph System Comments and Recommendations(PDF - 336KB) Leo Beletsky, JD, MPH: OTC Drug Review as a Regulatory Bottleneck: The Case of Naloxone(PDF - 1.2MB) Assuring Efficacy of Advanced Technology OTC Dosage Forms(PDF - 320KB) Lynne M. Szczepaniak and Ed Kuffner, MD: OTC Drug Monograph System: Past, Present, and Future March 25-56, 2014(PDF - 941KB) Kathleen A. Neville, MD, MS , FAAP: Improving OTC Drugs for Children(PDF - 174KB) David C. Steinberg, FRAPS: Updating the Regulations of OTC Drugs(PDF - 92KB) David R. Schoneker: Atypical Actives: Importance to OTC Drugs & and the Need for a Clear Regulatory Pathway for Use(PDF - 234KB) Paul Connett, PhD: FDA and OTC fluoride(PDF - 5.7MB)