New Legislation Imposes Document Reviews, Risk-Based Drug Inspections and Increased Drug Listing & Drug Registration Requirements
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August 01, 2012
Drugs, Law & Regulatory
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Tags: Administration and Safety Innovation Act, binder, coloring, drug, Excipient, FDA, FDASIA, gel coating, ingredients, inspections, listing, MDUFA, PDUFA, recalls, registration, suppliers
The Food and Drug Administration Safety and Innovation Act (S. 3187) was signed into law by President Obama on July 9th of this year. The Act brings numerous changes for the drug and medical device industry but all of the attention so far has been on the Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA) provisions and user fees. But there are considerable changes in the legislation to how FDA conducts “inspections” that dramatically increases (unnecessarily) the drug … READ MORE
