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US FDA Generic Approvals Peak In April, But Annual Pace Trends Down

Life Sciences Counsel Brian Malkin was recently quoted in a Pink Sheet article analyzing a surge in generic drug approvals during the month of April.

The US Food and Drug Administration’s Office of Generic Drugs issued its highest generic drug approval rate of 2020 during the month of April, the result of a “teleworking output surge.”

Higher approval rates during the months of March and April have been partially attributed to fewer distractions and the use of alternatives to in-person inspections as many FDA workers have been teleworking due to the coronavirus pandemic. Quoting Brian, the article notes that “there are too many variables to say whether virtual or in-person inspections could slow the approval pace”; thus, this is an uncertain indicator of whether this trend will continue in the months ahead.

Click here to read the article.


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