FDA OTC Monograph Changes Coming: User Fees, Pre-submission Meetings and Electronic Submissions

FDA User Fees for Reliance on the FDA OTC Monographs? Although not included in FDARA, there is a reasonable possibility the proposed Over-the-Counter Monograph User Fee Program (OMUFA) will still become law. Assuming passage, Over-the-Counter (OTC) User Fees and electronic submissions will be required and sponsors will have the opportunity to engage in pre-submission meetings…

Rx-to-OTC Switches Represent Huge Market Potential

Rx-to-OTC switches and the related repositioning of pharmaceutical products from prescription (Rx) dispensing to the retail (over-the-counter or OTC) drug space represent huge market potential. A Strong Domestic OTC Market The U.S. market for OTCs more than doubled between 2007 and 2013 growing from $16 billion to $33 billion. [1] By the beginning of 2014,…

Transcript for FDA’s Rx to OTC Meeting

As was previously promised, here are the transcripts (1 2) from FDA’s meeting entitled “Utilizing Innovative Technologies and Other Conditions of Safe Use To Expand Access to Nonprescription Drugs.” Contact us to find out how our experience can help your company expand your line of prescription and OTC products.

Prescription to OTC: PDG Attends FDA Public Hearing on Expanded Access to Nonprescription Drugs

The agency held a public hearing on March 22-23, 2012 to “obtain input on a new paradigm we are considering. Under this paradigm, the Agency would approve certain drugs that would otherwise require a prescription for nonprescription use (also known as over-the-counter or OTC) under conditions of safe use.”  The hearing was preliminary with no…

PDG to attend FDA’s OTC Public Hearing

The agency recently announced a public hearing to “obtain input on a new paradigm we are considering. Under this paradigm, the Agency would approve certain drugs that would otherwise require a prescription for nonprescription use (also known as over-the-counter or OTC) under conditions of safe use.” Please let us know if you plan to attend…

Time and Extent Applications for Nonprescription Drug Products (OTC) Guidance Introduced

According to FDA, “This guidance is intended to explain what information an applicant should submit to the Food and Drug Administration (FDA) to request that a drug product be included in the over-the-counter (OTC) drug monograph system and to describe the process for submitting that  information. FDA regulations set forth criteria and procedures by which…