Nearly three months after Canadian generics firm Apotex was put on import alert by the US Food and Drug Administration (FDA), the agency has released the text of a Warning Letter issued to the company ...
The US Food and Drug Administration (FDA) has warned Brassica Pharma for numerous good manufacturing practice (GMP) violations, including multiple instances of employees falsifying sterility and ...
The pharmaceutical industry’s approach to data integrity has been historically manual, leveraging physical documentation and potentially unreliable paper-based ...
Cathy Burgess, Benjamin Wolf, Jong Ho "Philip" Won, Ph.D. The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, ...
Following Viatris’ December announcement that a manufacturing plant in India had been written up by the FDA, a document published by the U.S. regulator reveals the details behind the company's ...
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