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FDA Makes Good on Its Promise to Regulate Laboratory-Developed Tests
The National Law Review· 1 day agoYesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and...
FDA Finally Moves to Scrutinize Specialized Health Screenings
ProPublica· 1 day ago“This is a significant step forward,” said Peter Lurie, president and executive director of the...
Cottage cheese and sour cream are safe amid bird flu outbreak, FDA says
NBC News via Yahoo News· 13 hours agoIs dairy safe to eat? New FDA tests find that pasteurization is effective against the bird flu virus...
Merck reports data from Phase III gastric cancer treatment trial
Clinical Trials Arena via Yahoo Finance· 56 minutes agoAn earlier interim analysis had demonstrated that the Keytruda regimen met the other primary...
FDA finalizes rule to increase oversight of lab tests
Boston Herald· 2 days agoThe rule effectively reclassifies tests developed and performed in a lab as medical devices for the...
No avian flu virus detected in sour cream, cottage cheese, powdered infant formula: FDA
Good Morning America via Yahoo News· 15 hours agoDepartment of Agriculture, Dr. Donald Prater, acting director of the Center for Food Safety and...
To save lives, the FDA must change how it evaluates rare disease treatments
Salon.com· 24 hours agoFor some conditions, few approved treatments exist. Without accelerated approval, the FDA is failing...
Bird flu testing shows more dairy products are safe, US FDA says
Reuters via AOL· 16 hours ago(Reuters) -Preliminary results of tests on additional dairy products show that pasteurization...
Neurocrine bags FDA approval for new ‘sprinkle’ Ingrezza formulation
Pharmaceutical Technology via Yahoo Finance· 18 hours agoThe US Food and Drug Administration (FDA) has approved an alternative formulation for Neurocrine...
Monogram Provides Regulatory Update Following Meeting with FDA
Digital Journal· 21 hours agoFood and Drug Administration (the "FDA"). On April 19, 2024, Monogram received written feedback from the FDA regarding the Company's Q1 2023 pre-submission ...