Last year's FDA Amendments Act will bring historic change to the agency and the industry, the likes of which has not been experienced for decades, according to the FDA director of new drugs, John Jenkins, MD. And that's without considering even bigger changes many see in a bill being circulated for discussion on Capitol Hill, the draft FDA Globalization Act, which could become law next year.
“When the history of FDA from this period is written,” Jenkins told the Drug Information Association's annual meeting in Boston, “it can only be compared with the profound changes that occurred following amendments to food and drug legislation that were passed in 1962.”
One example is the ongoing transition from paper to e-communications between industry and the agency. This was discussed at the meeting by panelist Gary Gensinger, deputy director of the FDA drug center's Office of Business Process Support.
He cautioned against the over-use of hyperlinks to references in product applications, including “cross application” links that are submitted electronically.