New harmonised guidance for post-approval changes released b

New harmonised guidance for post-approval changes released by FDA


New harmonised guidance for post-approval changes released by FDA
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The FDA has published its finalised guidance for drug lifecycle management, including an improved framework for the management of post-approval changes.
The US Food and Drug Administration (FDA) has released its final guidance for industry with new International Council for Harmonisation (ICH) guidelines, providing a more predictable and efficient framework for the management of post-approval chemistry, manufacturing and controls changes.
According to the FDA, the recommendations discuss how to identify the elements in an application that are considered necessary to assure product quality and therefore would require a regulatory submission if changed post-approval.

Related Keywords

Michael Kopcha , International Council For Harmonisation , Drug Administration , Office Of Pharmaceutical Quality , International Council , Pharmaceutical Quality , Drug Evaluation , Biologics Evaluation , மைக்கேல் கோப்சா , அலுவலகம் ஆஃப் மருந்து தரம் , சர்வதேச சபை , மருந்து தரம் , மருந்து மதிப்பீடு , உயிரியல் மதிப்பீடு ,

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