Randi Hernandez

Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.

Articles by Randi Hernandez

A new FDA Q&A document released on Jan. 12, 2016 describes 180-day exclusivity for generic-drug manufacturers and explains the number of conditions under which an abbreviated new drug applicant (ANDA) submitting a paragraph IV certification would forfeit eligibility to be the authorized generic manufacturer of a drug.

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