News

Biotechnology Industry Organization (BIO) President and CEO, Dr. Michelle McMurry-Heath, released the following statement following the announcement that Congress reached an agreement on the Prescription Drug User Fee Act (PDUFA): “For 30…

Dr. Michelle McMurry-Heath, president & CEO of the Biotechnology Innovation Organization, released the following statement in response to the Biden Administration’s “Advancing Biotechnology and Biomanufacturing” Executive Order: “BIO welcomes…

On Friday, September 23rd, BIO submitted comments in response to a new draft guidance describing FDA’s perspective on its use of remote regulatory assessments (RRAs). In particular, the draft guidance responded to frequently asked questions on what…

On Monday, September 26th, BIO submitted comments in response to the FDA’s draft guidance on clinical pharmacology considerations for development of oligonucleotide therapeutics, which provided recommendations on when certain PKPD assessments may be…

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…

BIO files amicus brief in support of a petition for rehearing related to patent-eligibility of diagnostic technology.