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Policy News
Friday, February 16, 2018   (0 Comments - view/add)
House Advances a Key BIO Legislative Priority »
The biotech community achieved an important legislative win yesterday. The U.S. House of Representatives passed with stron...
Thursday, January 18, 2018   (0 Comments - view/add)
IRS Won’t Enforce Penalties on Medical Device Tax »
SOURCE   The U.S. Internal Revenue Service yesterday said it won’t enforce penalties on companies making l...
Saturday, May 6, 2017   (0 Comments - view/add)
MichBio Thanks Sen. Stabenow for Leadership on Farm Bill »
ANN ARBOR, MI. ( May 6, 2017 ) – Today, MichBio , a leading voice for the bioscien ces industr...
Monday, February 13, 2017   (0 Comments - view/add)
Bill Would Ease Process for Companies in Michigan Border Towns to Receive Incentives »
KALAMAZOO — Legislation that passed the state Senate last Thursday seeks to level the playing field for economic developme...
Friday, July 29, 2016   (0 Comments - view/add)
Communication Guidelines for Drug Manufacturers Issued by PhRMA and BIO »
Two national industry groups, Pharmaceutical Research & Manufacturers Association (PhRMA) and Biotechnology Innovation...
Tuesday, March 22, 2016   (0 Comments - view/add)
U.S. House Rep Targets Direct-To-Consumer Drug Advertising »
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...
Tuesday, March 22, 2016   (0 Comments - view/add)
Senate Bill Proposes to Empower FDA Talent Recruitment and Retention »
The FDA and NIH Workforce Authorities Modernization Act was introduced in the Senate by Sens. Lamar Alexander (R-Tenn.)...
Tuesday, March 22, 2016   (0 Comments - view/add)
Powdered Gloves to be Prohibited? »
The FDA announced a proposal to ban most powdered gloves in the United States due to risk of various adverse events, inc...
Friday, February 26, 2016   (0 Comments - view/add)
Senate Ag Markup of Biotech Labeling Bill Postponed Amid Lack of Democratic Support »
WASHINGTON - The markup scheduled for Thursday for Senate Agriculture Committee Chairman Pat Roberts' voluntary biotech la...
Friday, February 26, 2016   (0 Comments - view/add)
Dr. Robert Califf Wins Senate Confirmation to Run F.D.A. »
WASHINGTON — President Obama’s pick to run the   Food and Drug Administration , Dr. Robert M. Califf, was finally co...
Monday, February 22, 2016   (0 Comments - view/add)
FDA Offers Free, Continuing Education Course to Help Health Care Providers Understand ‘Biosimilars’ »
You may have heard about a new category of products called “biosimilars.” What are biosimilars and how do they relate to b...
Monday, January 25, 2016   (0 Comments - view/add)
GAO Report Hammers FDA for Lax Oversight on Speedily Approved Drugs »
These days, the   FDA   is approving more and more drugs under its expedited programs, meaning new treatments ar...
Monday, January 25, 2016   (0 Comments - view/add)
BIO Applauds Move to Advance Senate Innovation Initiative Legislation »
Washington, D.C. (January 20, 2016) – The   Biotechnology Innovation Organization   (BIO) applauds the release y...
Monday, January 25, 2016   (0 Comments - view/add)
PhRMA, BIO Double Down on Biosimilar Naming With FDA Petition »
The nontrivial issue of how biosimilars should be named in the US may not go away until the US Food and Drug Administratio...
Monday, December 21, 2015   (0 Comments - view/add)
Victory! Long Sought Measures Passed by Congress »
Last Friday, the Senate passed a combined omnibus appropriations and tax extenders package 65-33 (27 Rs and 38 Ds).&nbs...
Thursday, December 17, 2015   (0 Comments - view/add)
Suspension of Medical Device Tax Proposed »
Congressional negotiators have reached an agreement on a large-scale tax extenders package as part of an omnibus govern...
Friday, November 20, 2015   (0 Comments - view/add)
United4Innovation: Help Repeal the Device Tax »
     The Affordable Care Act created a new tax on medical devices that took effect in 2013. ...
Wednesday, November 18, 2015   (0 Comments - view/add)
Stabenow Introduces Production Tax Credit for Renewable Chemicals »
Last week, Senator Debbie Stabenow (D-MI) and co-sponsors Senators Chris Coons (D-DE) and Al Franken (D-MN) introduce...
Wednesday, November 18, 2015   (0 Comments - view/add)
MichBio Helps Push Biosimilars Substitution Legislation Through Michigan House »
Legislation that would regulate the sale and distribution of biosimilar drugs has cleared the Michigan House by a 101-5 vo...
Wednesday, September 23, 2015   (0 Comments - view/add)
Senate Attempts to Pass Preserve Access to Affordable Generics Act »
The Preserve Access to Affordable Generics Act (S. 2019) was introduced last week as the latest attempt to address pharm...
Wednesday, September 23, 2015   (0 Comments - view/add)
Michigan Senate Urges Support for Federal GMO Labeling Law »
The Michigan Senate Agriculture Committee took up consideration of SR 59  at a hearing last week. The bill moved out...
Wednesday, September 23, 2015   (0 Comments - view/add)
State Rules to Change for Pharma Companies »
The Michigan House Committee on Health Policy voted out unanimously a  substitute bill H-1 for SB 195 , that would...
Wednesday, September 23, 2015   (0 Comments - view/add)
Bipartisan Senate Bill Aims To Accelerate Orphan-Drug Development »
The Advancing Targeted Therapies for Rare Diseases Act of 2015 (S. 2030) was introduced in the Senate on Tuesday by U.S....
Tuesday, September 22, 2015   (0 Comments - view/add)
Patient Engagement Advisory Committee Established by FDA »
Today the FDA is announcing the establishment of the Patient Engagement Advisory Committee (PEAC) to help assure that th...
Monday, August 31, 2015   (0 Comments - view/add)
FDA Issues Guidance on Naming of Biosimilars, Sort of »
The FDA, in a new rule , draft guidance , and blog post , proposes distinct non-proprietary names for biologic and bios...
Monday, August 31, 2015   (0 Comments - view/add)
Device Export Fees, GUDID, PDUFA, and Other Regulatory News »
New Device Export Certificate Fees The FDA issued a Federal Register (FR) Notice announcing revised fees for medic...
Monday, August 31, 2015   (0 Comments - view/add)
New Legislative Solution Proposed for LDTs »
The Association of Molecular Pathology (AMP), which represents molecular pathologists and has been an active participant i...
Monday, August 31, 2015   (0 Comments - view/add)
Coordinated Registries Network for Medical Device Evaluation Recommended »
A national coordinated registries network that monitors medical devices after they are made commercially available would m...
Monday, August 31, 2015   (0 Comments - view/add)
Refuse to Accept Policy for 510(k)s »
The FDA’s Center for Devices and Radiological Health (CDRH) issued a revised version of the guidance document “ Refuse to...
Monday, August 31, 2015   (0 Comments - view/add)
FDA Releases White Paper on the Speed of Drug Discovery and Development »
The FDA discusses the speed of drug discovery and development in a white paper, titled “ Targeted Drug Development: Why Ar...
Monday, August 31, 2015   (0 Comments - view/add)
Combination Products Regulatory Fairness Act Introduced »
A bill was introduced in the U.S. Senate last month entitled, “ The Combination Product Regulatory Fairness Act of 2015 .”...
Wednesday, July 29, 2015   (0 Comments - view/add)
Senators Introduce Bill to Streamline Patient Access to Medical Devices »
Bipartisan Legislation Will Increase Patient Options, Remove Red Tape  U.S. Senators Rob Portman (R-Ohio), Mar...
Thursday, July 16, 2015   (0 Comments - view/add)
Final Guidance on Planned Exemption of Certain Devices »
The FDA released a final guidance recently entitled, " Intent to Exempt Certain Unclassified, Class II, and Class I Reserv...
Thursday, July 16, 2015   (0 Comments - view/add)
Draft Guidance Issued on Factors to Consider When Making Benefit-Risk Determinations for IDEs »
FDA issued a draft guidance, " Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigatio...
Thursday, July 16, 2015   (0 Comments - view/add)
21st Century Cures Act Passes House Overwhelmingly »
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...

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