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BIO Comments: Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access

Bio Comments on Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access (Docket No. FDA-2017-N-3615)

The Biotechnology Innovation Organization (“BIO”) welcomes the opportunity to submit written comments to supplement our previous live testimony to the FDA’s open docket on the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access. BIO appreciated the opportunity to participate in FDA’s July 18th public meeting on this important topic and we are happy to supplement the record with these written comments. 

 

BIO also supplemted the comments we filed on September 19, 2017 to better inform the Docket on Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access. 1 Following submission of our comments pursuant to the initial closing date, other stakeholder comments were filed that raise issues of significant concern to BIO and our members. To ensure stakeholder interests in this issue are fully and accurately reflected, BIO submits these supplemental comments for FDA’s consideration

Bio Comments on Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access