FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...
The Food and Drug Administration (FDA) has put four companies on notice for marketing “unapproved fluoride-containing ingestible drugs” for use by children under the age of 3 or children at low or ...
FDA finds widespread quality issues at three Philips medical device facilities, citing violations in manufacturing and complaint handling.
The FDA has sent Philips a warning letter over three ultrasound and enterprise informatics facilities in the U.S. and the Netherlands.
We wanted to know where a widely used prescription drug that treats high cholesterol was manufactured and whether the factory ...
As excitement around animal testing alternatives reaches a fever pitch, Charles River Laboratories is making a move to strengthen its development of new approach methodologies (NAMs) that can ...
It appears problems at Novo Nordisk’s recently acquired manufacturing facility in Indiana aren’t going to be solved any time soon. The FDA has tagged the former Catalent facility with an official ...
Elaine Chen covers biotech, co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70. A troubled Indiana ...
The DMK-led Tamil Nadu government has blamed the previous AIADMK regime for the shortfall in drug tests flagged by central auditors. The findings were part of a 2024 report by the Comptroller and ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback