Jenkins predicts historic changes from FDA Acts

Share this article:
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.
Share this article:
close

Next Article in Features

Email Newsletters

More in Features

FDA and off-label uses: a balancing act

FDA and off-label uses: a balancing act

FDA's current re-examination of its off-label promotion policies in light of the First Amendment is a delicate balancing act between its rock-solid traditional enforcement posture and a diverse new electronic ...

Read the complete August 2014 Digital Edition

Read the complete August 2014 Digital Edition

Click the above link to access the complete Digital Edition of the August 2014 issue of MM&M, with all text, charts and pictures.