CMC Changes for Biologics: FDA Offers Draft Guidance | RAPS

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Read the full article: CMC Changes for Biologics: FDA Offers Draft Guidance | RAPS:

""The updated guidance applies to certain biological products licensed under the Public Health Service Act (PHS Act), including in vitro diagnostics licensed under BLAs," though it does not apply to human cells, tissues, and cellular and tissue-based products; specified biotechnology and specified synthetic biological products; and biosimilar biological products subject to licensure under section 351(k) of the PHS Act. "

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FDA Guidance: Regulations Under a Mask? | Bloomberg BNA

Read the full article:  FDA Guidance: Regulations Under a Mask? | Bloomberg BNA:

"The Washington Legal Foundation, a free-market advocacy group and think tank, is charging that the Food and Drug Administration is leaning too heavily on guidance documents in lieu of regulations, undercutting the Administrative Procedure Act and causing excessive burdens on affected industries. The group said the FDA has released more than 2,000 guidance documents and draft documents, far too many for industry to keep track of."

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
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