OFFICE OF GENERIC DRUGS BIOAVAILABILITY RESEARCH EXPANDED
OFFICE OF GENERIC DRUGS BIOAVAILABILITY RESEARCH EXPANDED to include high-volume "model drugs" such as metoprolol, ranitidine, naproxen and piroxicam that "will have many ANDAs," OGD Supervisory Chemist Paul Schwartz, PhD, told attendees of the National Association of Pharmaceutical Manufacturers mid-year meeting June 15. FDA is building a scientific database on the manufacturing process for model drugs "to make the review process a more efficient process," Schwartz said. "It will reduce regulatory burden and that's what we really want to do."
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