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Uday Shetty
Providing Free Online Resources for the Pharmaceutical Professional.
Providing Free Online Resources for the Pharmaceutical Professional.
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FDA Acceptability of Standards from Alternative Compendia (BP/EP/JP)
FDA published an updated Manual of Policy and Procedure
(MaPP), 5310.7 that clears doubts about using alternative compendia. It is not uncommon for drug sponsors and applicants to
propose specifications for the excipients, drug substances, and drug products...

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FDA publishes guidance for industry: ANDA Submissions - Prior Approval Supplements Under GDUFA
On October 17, 2016, the FDA published the final guidance for industry, “ ANDA Submissions - Prior Approval Supplements Under GDUFA .”  This final guidance is intended to assist applicants preparing to submit prior approval supplements (PASs) and related am...

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