RFK Jr. vow to purge FDA sets up collision with Big Pharma
Kennedy has been most vocal about the FDA, an agency that oversees nearly $3 trillion in medicines, food and tobacco products ...
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Dr. Reddy's flagged by FDA over quality issues
The U.S. Food and Drug Administration ... procedures applicable to the quality control unit. The FDA also cited inadequate control over computers and other IT systems, as well as poor ...
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FDA commissioner: We need action and higher-quality research on ultra-processed foods
Researchers, public health and health care groups, advocates, industry, and the public must put tackling diet-related disease ...
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The critical role of data integrity in ensuring pharmaceutical quality
the need for complex data management systems, and the ongoing evolution of regulatory landscapes. Integrating novel ...
MassDevice15d
FDA clears second set of changes to iRhythm Zio AT to resolve warning letter
Rhythm Technologies (Nasdaq:IRTC) announced that the FDA granted 510(k) clearance for Zio AT design modifications and ...
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The benefits and challenges of FDA Fast-Track and Accelerated Approval in drug development
The FDA Modernization Act of 1997 established the Fast Track designation ... Since 2007 we have provided our clients with ...
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FDA grants marketing authorisation to Peytant’s AMStent system
“With the availability of the AMStent system, we hope to improve the palliative care and thereby the quality of life for these patients.” "FDA grants marketing authorisation to Peytant’s ...