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Drug & Device News
FDA Recruiting Drug Manufacturers for Pilot Import Program
The FDA is signing up drug companies for a pilot program to help it devise a system for ensuring the safety of drugs and drug components imported into the United States. The agency is asking for 100 volunteer companies to take part in the experiment that will, according to an FDA release, “assist the agency in its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program and that may not be compliant.” Drug company applicants may choose up to five of their products and submit them for selection in the pilot program. To take part in the program, the companies must be able to show that they maintain complete control over the drugs from the time of manufacture through entry into the United States. The incentive for manufacturers is that their qualifying pharmaceutical products can be imported more quickly.
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