US and EU regulators begin offering parallel scientific advice to generic drugmakers

The FDA and Eu­ro­pean Med­i­cines Agency col­lab­o­rate of­ten and meet reg­u­lar­ly, but the two drug reg­u­la­tors have now an­nounced that for the first time, they will be­gin of­fer­ing par­al­lel sci­en­tif­ic ad­vice for gener­ic drug­mak­ers as part of a pi­lot project.

The par­al­lel ad­vice will be­gin for com­plex gener­ic drugs as part of a vol­un­tary pi­lot project that ex­pands up­on FDA and EMA’s par­al­lel ad­vice for new drugs and bi­o­log­ics.

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