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8:49
YouTube
cGMP Made Easy
FDA Pharmaceutical Validation Guidance and ICH: What you must know
The FDA Validation Guidance and ICH: What you should know. Process validation can be defined generally as a series of activities taking place over the Product Lifecycle. The validation exercise establishes scientific evidence that a process is capable of consistently delivering a quality product. After 24 years, the FDA updated its process ...
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Food and Drug Administration FDA Approvals
FDA to streamline approvals of generic biologic drugs
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If a drug sounds too good to be true, it probably is. The story of U.S. Food and Drug Administration drug approvals is more complex than how the Wall Street Journal's editorial page makes it seem. Listen as FDA Commissioner Dr. Makary explains how pharmaceutical companies sell their sob stories through their lobbyists and advertising partners. | U.S. Department of Health and Human Services
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