by Beckinam Nowatzke | Aug 12, 2019
On August 6, 2019, the U.S. Food and Drug Administration (FDA) released a statement that Novartis AG withheld notifying FDA about falsified data found in preclinical animal studies until after their $2.1 million gene-therapy drug, Zolgensma, was approved. Zolgensma,...
by Beckinam Nowatzke | Apr 5, 2019
Design Control has been in the news lately, have you seen it? The devastating crashes of the Boeing 737 MAX planes in Indonesia and Ethiopia have led to investigations and tough lessons learned for the airline industry, but the takeaways from the alleged cause of the...
by Beckinam Nowatzke | Apr 2, 2019
On March 13, 2019 the U.S. Food and Drug Administration (FDA) announced The Center for Devices and Radiological Health (CDRH) is beginning implementation of a reorganization that FDA hopes will create an agile infrastructure that can adapt to future organizational,...
by Beckinam Nowatzke | Dec 11, 2018
In a press release issued on November 26, 2018, the U.S. Food and Drug Administration (FDA) announced more details regarding an initiative to improve the 510(k) process. The modernization plan was previously announced as part of FDA’s Medical Device Safety...
