Press Releases
BIO Statement on PIPs Rule: EPA Misses…
The following statement concerning the Environmental Protection Agency’s final rule on regulation of Plant Incorporated Protectants (PIPs) under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) may be attributed to John Murphy, chief…
FDA Commissioner Dr. Robert Califf to Address…
BIO CEO Rachel King and Califf will discuss
issues impacting FDA and the biotech community
WASHINGTON - (May 25, 2023) – Robert Califf, commissioner of the Food and Drug Administration, will be the keynote speaker on day three of the 2023 BIO…
Katie Couric, Award-Winning Journalist and Health…
BIO CEO Rachel King and Couric to Discuss How Standing Up for Science and Patients Are at the Heart of Biotech
WASHINGTON - (May 16, 2023) – Katie Couric, award-winning journalist, New York Times best-selling author, and longtime cancer…
Letters, Testimony, & Comments
BIO Comments to FDA (Docket No. FDA-2023-N-0398)…
In these comments, BIO addresses FDA’s four specific topic areas of consideration as the agency develops its draft guidance per PDUFA VII.
Letter in support of U.S. Codex Office funding
BIO joined with more than 40 groups in calling on Congress to set 2024 funding for the U.S. Codex Office at or above the 2023 level.
BIO Comments to the FDA on Clinical Trial…
BIO’s comments support accelerated approval as an important regulatory pathway that allows patients with serious and life-threatening illnesses such as cancer to have earlier access to promising therapies.
Amicus Briefs
BIO Files Amicus Brief in U.S. ex rel. Scutte v…
BIO has filed an amicus brief in U.S. ex rel. Scutte v. SuperValu Inc., which addresses the issue of the intent requirement under the False Claims Act (FCA). Specifically, BIO urges the Court to uphold the view that a firm does not…
BIO JOINS AMICUS BRIEF CHALLENGING COURT’S…
The Biotechnology Innovation Organization (BIO) today signed onto an amicus brief to challenge a District Court’s unprecedented ruling (related to a single drug known as mifepristone) that would create regulatory barriers and potentially upend FDA’s…
BIO Files Amicus Brief in Petition for a Writ of…
BIO and AUTM have filed an amicus brief in petition for a writ of certiorari the in American Axle & Manufacturing, Inc., v. Neapco Holdings LLC, et al., at the Supreme Court of the United States. BIO and AUTM are concerned that…
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