Transcript for FDA’s Rx to OTC Meeting

Labeling / Marketing, News, Pharmaceutical Consulting News, Regulatory Affairs, Regulatory Updates, Research & Development, Submissions

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

Labeling / Marketing, Pharmaceutical Consulting News, Regulatory Affairs, Regulatory Updates, Research & Development, Submissions

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…