MIWG was formed in 2006 to seek clarity in the FDA regulatory scheme regarding the dissemination of truthful non-misleading information about prescription drugs, biological products and medical devices, and to improve the federal regulatory framework and enforcement climate affecting manufacturer dissemination of information regarding those products (including products in development and new uses of marketed products).

Resources

FDA Submissions and Amicus Briefs Filed on Behalf of MIWG Members.

Re: Draft Guidance for Industry: Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers (Docket No. FDA-2014-D-0447)
September 9, 2024
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Revised Draft Guidance for Industry: “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (Docket No. FDA-2008-D-0053)
January 5, 2024
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Re: Draft Guidance for Industry: “Regulatory Considerations for Prescription Drug Use-Related Software” (Docket No. FDA-2023-D-2482)
December 28, 2023
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UNITED STATES, EX REL. TRACY SCHUTTE, ET AL., PETITIONERS v. SUPERVALU INC., ET AL.
March 1, 2023
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United States v. William Facteau: Brief of Members of the Medical Information Working Group as Amici Curiae in Support of Reversal
July 28, 2021
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United States v. Patrick Fabian: Brief of Members of the Medical Information Work Group as Amici Curiae in Support of Reversal
July 28, 2021
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Regulations Regarding “Intended Uses”
June 30, 2021
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MIWG Comments on Intended Use Proposed Rule
October 23, 2020
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Medical Information Working Group (MIWG); Recent Case Law Developments
November 21, 2019
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COMMENT FROM THE MEDICAL INFORMATION WORKING GROUP RE: Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments (Docket No. FDA-2018-N-3017) (January 22, 2019)
January 23, 2019
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Regulation To Require Drug Pricing Transparency; Request for Comments, Docket No. CMS-4187-P, 83 Fed. Reg. 52,789 (Oct. 18, 2018)
December 17, 2018
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Amendments to Regulations Regarding “Intended Uses”; Proposed Partial Delay of Effective Date (Docket Nos. FDA-2015-N-2002, FDA-2017-D-4792, and -6580)
February 5, 2018
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Review of Existing CDER/CDRH Regulatory and Information Collection Requirements; Request for Comments and Information (Docket Nos. FDA-2017-N-501 and FDA-2017-N-5105).
December 7, 2017
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Comment from the Medical Information Working Group re: FDA's Draft Guidance on Microneedling Devices
November 14, 2017
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Comment from the Medical Information Working Group re: FDA's "Intended Use" Final Rule
July 18, 2017
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Comment from the Medical Information Working Group re: Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products
April 19, 2017
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Request for Extension from MIWG, PhRMA and BIO
April 5, 2017
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Petition to Stay and for Reconsideration
February 8, 2017
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Testimony prepared for Food and Drug Administration (FDA) hearing on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.
November 9, 2016
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Amicus Brief in United States v. Facteau and Fabian
September 19, 2016
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Comment to FDA Proposed Rule Regarding Amendments to Intended Use Regulations
November 24, 2015
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Amicus Brief in Pacira Pharmaceuticals, Inc. v. FDA
October 15, 2015
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Amicus Brief in Amarin Pharma, Inc. v. FDA
June 11, 2015
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White Paper: Systemic, Societal, and Legal Developments Require Changes To FDA’s Regulation of Manufacturer Speech
October 31, 2014
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Use of Health Care Economic Information Under Section 114 of the Food and Drug Administration Modernization Act
October 31, 2014
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Comments to FDA Draft Guidance for Industry: Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices
September 16, 2014
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Comments to FDA Draft Guidance for Industry: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices
September 16, 2014
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Comments to FDA Draft Guidance for Industry: Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products - Recommended Practices
August 25, 2014
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Comments Re FDA Draft Strategic Priorities for 2014–2018
July 31, 2014
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Comments to FDA Draft Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses - Recommended Practices
May 2, 2014
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Comment to FDA Draft Guidance for Industry: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics
April 14, 2014
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Comments re FDA Safety and Innovation Act Section 907 Report
November 20, 2013
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Second Citizen Petition Submitted to FDA on Behalf of Members of the MIWG
September 3, 2013
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Comments re CDER Medical Policy Council
July 16, 2013
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Letter to FDA re Fox II and Caronia Decisions
March 1, 2013
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Comments to FDA re Scientific Exchange and Draft Guidance to Industry on Unsolicited Requests
March 27, 2012
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Amicus Brief in United States v. Caronia
August 22, 2011
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First Citizen Petition Submitted to FDA on Behalf of Members of the MIWG
July 5, 2011
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Comments re FDA Transparency Task Force
April 15, 2010
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Comments to FDA Draft Guidance for Industry: Good Reprint Practices for the Distribution for Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices
April 18, 2008
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