BIO Comments on FDA Draft Guidance on How to Prepare a Pre-Request for Designation (Pre-RFD)
April 13, 2017
BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, How to Prepare a Pre-Request for Designation (Pre-RFD).
BIO supports continued improvements to the review process of combination products. BIO says the draft guidance promotes early dialogue between sponsors seeking approval of combination products and the FDA. BIO provides additional suggestions to help clarify the draft guidance.
On behalf of its member organizations, Biotechnology Innovation Organization (“BIO”) respectfully submits this Comment in response to the United States Patent and Trademark Office’s (the “Patent Office” or “PTO”) February 13, 2024 Request for…
BIO submits comments on the MDH’s proposed regulations regarding Drugs of Substantial Public Interest: Draft Methodology for Public Comment as required in statute by the Prescription Drug Price Transparency Act.
BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, How to Prepare a Pre-Request for Designation (Pre-RFD).
BIO supports continued improvements to the review process of combination products. BIO says the draft guidance promotes early dialogue between sponsors seeking approval of combination products and the FDA. BIO provides additional suggestions to help clarify the draft guidance.