Friday, December 22, 2017

CMC Changes for Biologics: FDA Offers Draft Guidance | RAPS

Read the full article: CMC Changes for Biologics: FDA Offers Draft Guidance | RAPS: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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Friday, December 15, 2017

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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FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
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Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!