logo
Plus   Neg
Share
Email

Novartis Pledges To Release Information On Manipulated Data In Future

Novartis (NVS) has committed to notifying the Food and Drug Administration within five business days of learning of any "credible allegation" in which manipulated data may affect a pending marketing application before the agency or regulators in other countries.

"We are making a voluntary commitment to notify the FDA within five business days of receipt by our quality (control) organization of any credible allegation related to data integrity impacting any pending application in the Novartis Group," Chief Executive Officer Vas Narasimhan said at an investor event. The company will take a similar approach in other jurisdictions.

The commitment was made to the FDA last month as part of a formal response to an August 2 inspection report of a facility.

The report noted that Novartis apparently first became aware of manipulated data concerning a gene therapy last March, but waited to inform the agency until after the treatment was approved in May.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
The United Auto Workers at General Motors will remain on strike until ratification of a new four-year labor contract, the union said on Thursday. GM's proposed agreement includes an $11,000 ratification bonus to workers, wage increases of 4 percent throughout the four-year contract, no increases in health care costs; and a path to permanent worker status within four years or less. Streaming giant Netflix Inc. (NFLX) announced that it secured rights to Jeff Smith's critically acclaimed comic book series BONE. Netflix said it plans to develop an animated kids series based on BONE that follows the iconic Bone cousins on an adventure through a vast, uncharted desert and into a... Swedish luxury auto maker Volvo Cars unveiled its first fully electric car, the XC40 Recharge. The XC40 Recharge is a part of the electrified car portfolio that Volvo plans to introduce under the new 'Recharge' sub-brand. The company said it plans to launch a fully electric car every year over the...
Follow RTT
>