Pfiz­er and oth­er bio­phar­mas to FDA: Don't in­clude CMOs in new re­port­ing re­quire­ments on drug vol­ume

As the FDA is look­ing to re­duce drug short­ages fur­ther by col­lect­ing more da­ta on the vol­ume of drugs and APIs man­u­fac­tured world­wide, com­pa­nies like Pfiz­er, Ther­mo Fish­er, Vi­a­tris and in­dus­try groups are push­ing back on new guid­ance that seeks to es­tab­lish how that da­ta should be col­lect­ed and sub­mit­ted to the agency.

The tech­ni­cal con­for­mance guide, re­leased last Oc­to­ber, spells out the re­quire­ments un­der Sec­tion 3112(e) of the CARES Act, which was signed in­to law in March 2020 and added a new sec­tion to the FD&C Act.

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