Post-Market Monitoring Can Fill Innovative Switch Data Gaps

Post-Market Monitoring Can Fill Innovative Switch Data Gaps – Consultants

Allowing for post-market monitoring would incentivize sponsors to consider switches and generate data that could inform a decision about potential conditions for safe use “without applying potentially burdensome – and possibly unnecessary – conditions upfront,” Pinney Associates health care consultancy says.

Pinney Associates recommends FDA allow post-marketing surveillance as a condition of safe use for innovative switches rather than requiring all questions about a product’s suitability for nonprescription use be resolved pre-market.

“Not only would allowing for post-market monitoring incentivize more sponsors to consider requesting Rx to OTC switches, but it would...