Preapproval Information Exchange Act Basics | AMCP Nexus 2024

According to Charlie Dragovich, Senior Director and Client Strategist at Cencora, the PIE Act allows the FDA to grant “an exception to some of their rules and regulations so that manufacturers and payers can feel comfortable pre approval having important discussions about a new product or a new line extension or a new medical device coming to market and preparing it so that it can come to market as quickly as possible.”

Discussions may take place around how many people will use the product and what it will cost.

Dragovich authored a poster titled, ‘Optimizing the timing of pre-approval information exchange (PIE) engagement for oncology products, products for rare diseases, and cell and gene therapies (CGTs),’ which was presented this week at AMCP Nexus 2024, held at the MGM Grand in Las Vegas.

Cencora is a drug wholesale company that partners with pharmaceutical companies and healthcare providers to facilitate care.