EU Says Nitrosamine Risk Info Also Needed For New Drug Filings
Incomplete Info May Impact Granting Of Marketing Authorization
Companies seeking approval of new drugs must provide information on nitrosamine-related risk evaluation either as part of their marketing application or during the evaluation process.
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EU regulators say that sponsors must complete their nitrosamine-related risk evaluations for all EU medicines containing chemically-synthesised active substances within the six-month timeframe.
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