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.
You may also be interested in...
The Quality Lowdown: Warning Letters, Nitrosamine Recalls And Sen. Warren's Generics Manufacturing Plan
Manufacturers warned on quality basics like testing and keeping records and reminded about nitrosamine deadlines; Senator Elizabeth Warren clarifies government drug manufacturing idea.
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.
While the Dutch government negotiates an acceptable price for Leadiant Biosciences’ orphan drug CDCA, a university hospital has resumed supplying pharmacy compounded versions of the drug after addressing initial problems with the sourcing of raw materials.