FDA, Generic Industry Continue Quest for Higher-Quality ANDA Submissions
Jun17

FDA, Generic Industry Continue Quest for Higher-Quality ANDA Submissions

The FDA’s Activities Report of the Generic Drug Program for May 2014 reveals that Refuse to Receive (RTR) notifications equaled Approvals at 20 (see complete chart below). The numbers will almost certainly come as a disappointment considering the attention being paid to improving the quality of ANDA submissions by sponsors of generic drug applications and the Office of Generic Drugs (OGD). This week the FDA published yet another draft...

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How the FDA Reviews and Validates Regulatory Submissions
May21

How the FDA Reviews and Validates Regulatory Submissions

Besides loading and validating submissions, VALIDATE is used to reject submissions for technical reasons. If VALIDATE reports a high error, your submission could be rejected. This rejection could take up to five days to be reported. When an original or supplement is rejected, your PDUFA time clock will not start.

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The Latest EU eCTD Submission Guidance

There has been a lot going on at the various European agencies in the last few months. This week, we look at some of the announcments and guidance documents that have been issued across Europe recently. France Caroline AURICHE, Philippe DÜRR and Cécile LEVY from AFSSAPS spoke at EXL Pharma, presenting on Taking the plunge from paper into electronic-only in the EU – the 18-month feed-back experience of «paperlessland» in the...

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