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Policy News
Thursday, July 16, 2015   (0 Comments - view/add)
White House to Update Biotechnology Framework »
The White House Office of Science and Technology Policy (OSTP) directed the FDA, USDA, and EPA to “improve the transparenc...
Thursday, July 16, 2015   (0 Comments - view/add)
MichBio Advocates to Protect Patent Rights, Oppose H.R. 9 »
MichBio is opposing H.R. 9, referred to as the Innovation Act . The legislation, introduced by House Judiciary Committee...
Thursday, July 16, 2015   (0 Comments - view/add)
Draft Guidance on UDI Direct Marking of Devices »
The FDA issued a draft guidance, “ Unique Device Identification: Direct Marking of Devices - Draft Guidance for Industry a...
Thursday, July 16, 2015   (0 Comments - view/add)
FDA Device Accountability Act »
The “ FDA Device Accountability Act ” was introduced recently in the U.S. Senate.  The bipartisan legislation me...
Tuesday, June 30, 2015   (0 Comments - view/add)
Ensuring Oversight and Transparency on Trade »
From Midland Daily News Op-ed by U.S. Rep. John Moolenaar The trade promotion authority (TPA) legislation recentl...
Tuesday, June 23, 2015   (0 Comments - view/add)
House Agriculture Appropriations Subcommittee Slashes Farm Energy Programs »
The agriculture subcommittee of the House Appropriations Committee passed their spending plans for Fiscal Year 2016. They...
Tuesday, June 23, 2015   (0 Comments - view/add)
Medical Device Tax Repeal Clears House in Historic Vote »
As a result of the tireless efforts of MichBio members, other state associations and their member companies, and the natio...
Tuesday, June 23, 2015   (0 Comments - view/add)
Public Meeting on Medical Device User Fee Reauthorization »
The Food and Drug Administration (FDA) is announcing a public meeting on the reauthorization of the medical device user fe...
Tuesday, June 23, 2015   (0 Comments - view/add)
State Bio’s to Host Annual Educational Briefing on Capitol Hill »
A number of state bioscience associations—MichBio, BIOCOM, BioNJ, BioUtah, BioWV, CBSI, CLSA, DelawareBio, HINJ, IMDMC, Li...
Tuesday, June 23, 2015   (0 Comments - view/add)
June Update: FDA Guidance Issued »
Medical Device IDE Draft Guidance FDA announced the availability of the draft guidance entitled, “ Factors to Consid...
Thursday, May 28, 2015   (0 Comments - view/add)
21st Century Cures Legislation Moves Forward in U.S. House »
The U.S. House Energy and Commerce Committee voted 51-0 to approve the  21st Century Cures Act . The Act is a cu...
Thursday, May 28, 2015   (0 Comments - view/add)
Adaptive Designs for Medical Device Clinical Studies and Other FDA Guidance Releases »
Adaptive Designs for Medical Device Clinical Studies - Draft Guidance for Industry and Food and Drug Administration Staff...
Thursday, May 28, 2015   (0 Comments - view/add)
Slew of FDA-Related Bills Introduced in Congress »
Numerous legislators decided to introduce stand-alone bills, either breaking out provisions from the 21st Century Cures Ac...
Thursday, May 28, 2015   (0 Comments - view/add)
Educational Briefing on Biosimilars for State Legislators »
MichBio facilitated an education briefing “Overview Breakfast: Biosimilars – NextGen Therapies” on behalf of the Michigan...
Wednesday, April 29, 2015   (0 Comments - view/add)
Device Tax Hearing Held by Senate Finance Healthcare Subcommittee »
The Subcommittee on Health Care of the U.S. Senate Finance Committee held a hearing last week “A Fresh Look at the Impact...
Wednesday, April 29, 2015   (0 Comments - view/add)
Device Advisory Committee Meeting Procedures and Other FDA Guidance Releases »
The Food and Drug Administration (FDA) issued numerous guidance documents over the last month. They include the following:...
Wednesday, April 29, 2015   (0 Comments - view/add)
Licensing Rules Refined for Drug and Device Manufacturers/Wholesalers in Michigan »
The State of Michigan Licensing & Regulatory Agency (LARA) and the Attorney General Office (AGO) have further clarifie...
Wednesday, April 29, 2015   (0 Comments - view/add)
Personal Care Products Safety Act Introduced »
A Personal Care Products Safety Act ( S. 2014 ) bill was recently introduced in Congress that would significantly exp...
Tuesday, April 28, 2015   (0 Comments - view/add)
Patent Abuse and 21st Century Cures Headline BIO Fly-In »
MichBio joined more than 300 biotechnology industry leaders from over 40 states during the recent BIO Legislative Day Fly...
Friday, March 20, 2015   (0 Comments - view/add)
FDA Seeks External Collaborations to Support Regulatory Science Needs »
The FDA announced the availability of a report entitled, “ Assessing the Center for Drug Evaluation and Research’s [CDER]...
Friday, March 20, 2015   (0 Comments - view/add)
Draft Guidance on Formal Meetings Between Applicants and FDA »
The FDA announced the availability of a draft guidance for industry entitled, “ Formal Meetings Between the FDA and Sponso...
Friday, March 20, 2015   (0 Comments - view/add)
Electronic Informed Consent Guidance Issued »
The FDA announced the availability of a draft guidance, “ Use of Electronic Informed Consent in Clinical Investigations ,"...
Friday, March 20, 2015   (0 Comments - view/add)
Rules for Disinfecting Reusable Medical Devices Finalized by FDA »
The FDA announced the availability of a final guidance for industry entitled, “ Reprocessing Medical Devices in Health Car...
Thursday, February 19, 2015   (0 Comments - view/add)
Michigan Device Companies Get Temporary Licensure Relief »
Device manufacturers, wholesalers, and distributors who were ensnared unwittingly by a new Pharmacy Practice and Drug Con...
Friday, January 30, 2015   (0 Comments - view/add)
Medical Device Companies Under Threat in Michigan »
  A new Pharmacy Control and Drug Practice law, Public Act 280 , in Michigan that took effect as of September 30,...
Friday, January 30, 2015   (0 Comments - view/add)
R&D Support and Immigration Challenge Bio-Industry Growth »
U.S. Losing Ground as R&D Leader   The U.S. is losing ground in its leadership of medical research spendin...
Friday, January 30, 2015   (0 Comments - view/add)
Medical Devices Federal Updates »
  Medical Device Tax Repeal Re-Introduced in Congress   Legislation to repeal the medical device exc...
Friday, January 30, 2015   (0 Comments - view/add)
Biotech-Pharma Federal Updates »
    Save the Date! BIO Legislative Fly-In is March 14-15, 2015   MichBio invites execu...
Wednesday, July 2, 2014   (0 Comments - view/add)
Federal, State, and International Advocacy Alert: July 2, 2014 »
Policymakers at the FDA were extremely busy over the last several weeks. Highlights of the many final and proposed regulat...
Tuesday, June 10, 2014   (0 Comments - view/add)
Critical: FDA Issues Initial UDI Database Guidance »
The following communication was received from the FDA regarding implementation of the Unique Device Identification system....
Friday, June 6, 2014   (0 Comments - view/add)
Federal Policy Advocacy Alert: June 6, 2014 »
House Energy & Commerce Subcommittee To Review Incentives for Drug Development The House Energy & Commerce Subco...
Friday, May 9, 2014   (0 Comments - view/add)
Federal Policy Advocacy Alert: May 9, 2014 »
FDA Seeks Company Partners for Experiential Learning Program FDA's Center for Devices and Radiological Health (CDRH) is...
Friday, April 25, 2014   (0 Comments - view/add)
Federal Policy Advocacy Alert: April 25, 2014 »
IP Protection & Biopharma/Medtech Product Development - Patent Reform, Again MichBio hosts its next Advocacy Update...
Tuesday, March 4, 2014   (0 Comments - view/add)
Federal Policy Advocacy Alert: March 4, 2014 »
Not much change with FDA's new 510(k) device modification rules In its report to Congress , the FDA Center for Devices...

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