FDA Reports on Postmarket Labeling Changes, Import Screening for Drugs
The Food and Drug Administration issued a report titled “Advances in FDA’s Safety Program for Marketed Drugs”, which describes the actions that the Center for Drug Evaluation and Research (CDER) has taken in recent years to enhance the quality, accountability, and timeliness of its postmarket drug safety decisions. The FDA also issued a companion report, “Regulatory Science in Action: Enhancing Drug Safety & Manufacturing Quality at FDA with Research”, which includes, among other things, a section on recent developments in import screening.
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Postmarket "Drug Label Change" Authority Used 65 Times Since 2008
The Report discusses, among other things, the FDA’s authority to require a change in a drug’s label to include new safety information. The FDA says that since 2008, the FDA has required new safety labeling 65 times using the authority granted to it by the Food and Drug Administration Amendments Act of 2007, generally for whole classes of drugs. According to the FDA, it is working to finalize its April 2011 draft guidance on implementation of this authority.
Five Pilot Programs Use Handheld Devices to Screen Imports
The FDA’s companion report, “Regulatory Science in Action”, highlights the use of new technologies in drug safety monitoring, including in the screening of imports to detect harmful products. In the companion Report, the FDA notes that the number of drug imports is increasing and the number of drug imports that the FDA wishes to examine based on risk also continues to increase. As a result, says the FDA, it is looking into the potential to use advanced portable technologies to rapidly screen a larger number of drug and dietary supplement products in the field, while only sending suspected tainted samples to the district laboratory for further investigation.
The FDA said technologies such as Raman and Near Infra-Red Spectroscopy, and Ion Mobility and X-Ray Fluorescence Spectrometry have been adapted for handheld use and similar technologies are being used to screen for explosives at airports. According to the FDA, in ongoing pilot programs, five portable ion mobility devices used for identifying dietary supplements containing undeclared drug ingredients have successfully been deployed across the U.S.
FDA report titled "Advances in FDA's Safety Program for Marketed Drugs" available here.
Highlights of the FDA "Advances in FDA Safety Program" report available here.
FDA companion report titled "Regulatory Science in Action: Enhancing Drug Security & Manufacturing Quality at FDA with Research" available here.