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17:02
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U.S. Food and Drug Administration
CDER BIMO: Electronic Submission Requirements for New Drug and Biologic Licensing Applications
The Food and Drug Administration issued the final guidance for industry entitled “Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions.” This guidance describes the electronic submission of certain data and information in standardized formats ...
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The Food and Drug Administration recently announced it would begin asking drug companies to remove so-called “black box” warnings for hormones prescribed to treat symptoms of menopause. The FDA says the warning has dissuaded generations of women from taking advantage of the medication that could help them. The move comes months after public health leaders faced criticism for a different decision. Despite years of scientific research, no study has shown that acetaminophen, the main ingredient in
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