What facilities produce what drugs for the U.S. market? FDA is committed to obtaining a more accurate answer to that question by requiring electronic registration and listing - and by knocking on doors if necessary. A registration fee could be coming, if pending legislation is any indication. Although the agency has long sought to improve its flawed paper drug registration and listing process, progress is much quicker with Congress reacting to fears of substandard ingredient suppliers in China. Under the new approach, all registered facilities will have unique numerical identifiers called DUNS numbers obtained from Dun & Bradstreet. Meanwhile, FDA is turning to commercial databases to clean up its list of drugs on the U.S. market - and flush out illegal unapproved drugs for targeted enforcement actions.
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England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.
The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.
Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.
