The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
The Food and Drug Administration may toughen is approval process for 510(k) clearance for medical devices, according to a report by the Wall Street Journal. The move causes concern for medical device ...
The Food and Drug Administration has released a new plan detailing 25 actions it plans to take in 2011 to improve the 510(k) approval process of medical devices, according to an FDA news release. In ...
April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...
The FDA has introduced ELSA, a groundbreaking AI tool designed to expedite the review process for drugs and medical devices. In a remarkable pilot, ELSA has proven to significantly reduce the time ...
When the 21st Century Cures Act passed the House in July 2015, public health experts began to warn against a connection between one measure included in the act, a huge increase in medical research ...
Initial module submission marks an important milestone in the pre-market approval process - - Flexible modular submission ...
“Washington bureaucracy and regulations far too often interfere with health care decisions of patients and their doctors,” said Sen. Ted Cruz (R-TX) in joining forces with Rep. Chip Roy (R-TX) to ...
In a recent interview, Food and Drug Administration Commissioner Marty Makary declared that Medicare should automatically cover FDA-designated breakthrough devices — a rare and refreshing commonsense ...
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