The Food and Drug Administration has extended until March 13 2014 the comment period for Supplemental Applications Proposing Labelling Changes for Approved Drugs and Biological Products, its proposed rule which would allow generic manufacturers to strengthen warnings using 'changes being effected' supplements. Both generic and brand-name pharmaceutical manufacturers should consider submitting comments during this extended period.
For further details on the proposed rule and its impact on pharmaceutical manufacturers, please see "Goodbye to generic preemption? FDA publishes proposed rule".
For further information on this topic please contact James W Huston, Erin M Bosman or Julie Y Park at Morrison & Foerster LLP by telephone (+1 858 720 5100), fax (+1 858 720 5125) or email ([email protected], [email protected], [email protected]). The Morrison & Foerster website can be accessed at www.mofo.com.
