Randi Hernandez

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

Articles

GE Healthcare: The Next Cell and Gene Therapy Manufacturing Giant?

April 11th 2017

GE Healthcare continues to ramp up its offerings in the bioprocessing space with the purchase of Asymptote and a continued partnership with Zenith Technologies.

FDA Approves First Treatment for Primary-Progressive Forms of Multiple Sclerosis

Randi Hernandez

March 29th 2017

The mAb is the first approved treatment that targets the progressive form of the disease.

FDA Clarifies How It Handles 180-Day Exclusivity

Randi Hernandez

January 18th 2017

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.