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Under the PDUFA regime, New Drug Applications and Biologics License Applications (together referred to as 'human drug applications' in the PDUFA context) are levied a fee upon filing. As of 2021, this fee was US$2,875,842 for applications requiring clinical data and US$1,437,921 for applications that do not. [4]
PDUFA dates are deadlines for the FDA to review new drugs. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review, the FDA is allotted 6 months to review the drug. These time frames begin on the date that an NDA is accepted by the FDA as complete.
In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application or Biologics License Application, indicating that the application will not be approved in its present form. [1]
September proved to be a mixed month as far as drug approvals are concerned, with Mallinckrodt PLC (NYSE: MNK) and Aquestive Therapeutics Inc (NASDAQ: AQST) facing rejections.PDUFA dates are ...
The busy calendar of June proved positive for drug approvals, with most scheduled events producing positive outcomes. New molecular entity, or NME, approval for the month totaled two, taking the ...
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In September 2020, the FDA accepted bluebird's marketing application for ide-cel in and established a PDUFA goal date of March 27, 2021. [14] US approval of ide-cel by March 31, 2021, is one of the required remaining milestones of the contingent value rights (CVR) issued upon the close of Bristol Myers Squibb's purchase of Celgene in 2019.
August was a pretty steady month for biotechs. In terms of new molecular entity or NME approvals, the month was productive, with the FDA giving the go-ahead for seven of these products containing ...