FDA Gives Firms One Month To Fix Listings Before Barring Drugs From US Market
Tens of thousands of listed drugs could be barred if manufacturers do not update their records.
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Agency issued final classification determinations within 90 days after an inspection 86% of the time in fiscal year 2019 and continues to reduce the time interval for sending GMP warning letters, CDER compliance director Donald Ashley tells FDLI conference.
The US FDA has issued guidance on how it will continue to use remote technology to assess agency regulated facilities, a practice that became popular during COVID-19 travel restrictions.
Agency provides additional details on plans for various remote methods of assessing Rx and OTC drug manufacturing facilities that became popular when investigators were prevented by COVID-19 travel restrictions from visiting sites in person.