U.S. Representatives Eliot L. Engel (NY-16) and Fred Upton (MI-06), top Members of the Energy and Commerce Committee, toda...

ANN ARBOR, MI. ( May 6, 2017 ) – Today, MichBio , a leading voice for the bioscien ces industr...

KALAMAZOO — Legislation that passed the state Senate last Thursday seeks to level the playing field for economic developme...

Two national industry groups, Pharmaceutical Research & Manufacturers Association (PhRMA) and Biotechnology Innovation...

A bill ( H.R. 4565 ) has been introduced by U.S. Rep. Rosa DeLauro (CT, D-3) that would place a three-year moratorium on d...

The FDA and NIH Workforce Authorities Modernization Act was introduced in the Senate by Sens. Lamar Alexander (R-Tenn.)...

The FDA announced a proposal to ban most powdered gloves in the United States due to risk of various adverse events, inc...

WASHINGTON - The markup scheduled for Thursday for Senate Agriculture Committee Chairman Pat Roberts' voluntary biotech la...

WASHINGTON — President Obama’s pick to run the   Food and Drug Administration , Dr. Robert M. Califf, was finally co...

You may have heard about a new category of products called “biosimilars.” What are biosimilars and how do they relate to b...

These days, the   FDA   is approving more and more drugs under its expedited programs, meaning new treatments ar...

Washington, D.C. (January 20, 2016) – The   Biotechnology Innovation Organization   (BIO) applauds the release y...

The nontrivial issue of how biosimilars should be named in the US may not go away until the US Food and Drug Administratio...

Last Friday, the Senate passed a combined omnibus appropriations and tax extenders package 65-33 (27 Rs and 38 Ds).&nbs...

Congressional negotiators have reached an agreement on a large-scale tax extenders package as part of an omnibus govern...

     The Affordable Care Act created a new tax on medical devices that took effect in 2013. ...

Last week, Senator Debbie Stabenow (D-MI) and co-sponsors Senators Chris Coons (D-DE) and Al Franken (D-MN) introduce...

Legislation that would regulate the sale and distribution of biosimilar drugs has cleared the Michigan House by a 101-5 vo...

The Preserve Access to Affordable Generics Act (S. 2019) was introduced last week as the latest attempt to address pharm...

The Michigan Senate Agriculture Committee took up consideration of SR 59  at a hearing last week. The bill moved out...

The Michigan House Committee on Health Policy voted out unanimously a  substitute bill H-1 for SB 195 , that would...

The Advancing Targeted Therapies for Rare Diseases Act of 2015 (S. 2030) was introduced in the Senate on Tuesday by U.S....

Today the FDA is announcing the establishment of the Patient Engagement Advisory Committee (PEAC) to help assure that th...

The FDA, in a new rule , draft guidance , and blog post , proposes distinct non-proprietary names for biologic and bios...

New Device Export Certificate Fees The FDA issued a Federal Register (FR) Notice announcing revised fees for medic...

The Association of Molecular Pathology (AMP), which represents molecular pathologists and has been an active participant i...

A national coordinated registries network that monitors medical devices after they are made commercially available would m...

The FDA’s Center for Devices and Radiological Health (CDRH) issued a revised version of the guidance document “ Refuse to...

The FDA discusses the speed of drug discovery and development in a white paper, titled “ Targeted Drug Development: Why Ar...

A bill was introduced in the U.S. Senate last month entitled, “ The Combination Product Regulatory Fairness Act of 2015 .”...

Bipartisan Legislation Will Increase Patient Options, Remove Red Tape  U.S. Senators Rob Portman (R-Ohio), Mar...

The FDA released a final guidance recently entitled, " Intent to Exempt Certain Unclassified, Class II, and Class I Reserv...

FDA issued a draft guidance, " Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigatio...

The U.S. House, in a rare act of bipartisanship, voted 344-77 on July 2 in favor of the 21st Century Cures Act , which su...

A federal Right to Try Act of 2015 (H.R. 3012) was introduced in the U.S. House of Representatives last week and referre...