1. Pink Sheet

The Power Of The Open Public Hearing

 
• By Michael McCaughan

The US FDA took three high profile applications to an external advisory committee meeting during the week of 8 May – and offered a very skeptical read on the approvability of each. All three won positive votes from the committees, in no small part thanks to the messages delivered during the Open Public Hearings.

FDA open public hearing
• Source: Nielsen Hobbs; the Pink Sheet | Shutterstock, Getty images

From a medical and scientific perspective, pending applications from Perrigo Company PLC/HRA for a potential over the counter oral contraceptive, from ARS Pharmaceuticals, Inc. for a novel intranasal formulation of epinephrine, and from Sarepta Therapeutics, Inc. for a gene therapy to treat DMD have almost nothing in common.

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