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Massachusetts Biotechnology Council

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Member News

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News

Four Ways FDA’s New Intended Use Regulations Affect Drug and Medical Device Companies

Nov 08, 2021

Posted by Sidley Austin

News

Regulators Offer Fresh Guidance on Using Real-World Data to Support Regulatory Decisions

Nov 08, 2021

Posted by Sidley Austin

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Five Ways FDA’s New Final Rule on Intended Use Could Affect Consumer Products

Nov 08, 2021

Posted by Sidley Austin

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How Artificial Intelligence Manufacturers Can Protect Themselves Against Future Negligence Claims

Nov 08, 2021

Posted by Sidley Austin

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HHS Announces Withdrawal of Good Guidance Practices and Fairness in Enforcement Rules

Nov 08, 2021

Posted by Sidley Austin

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U.S. Agencies Issue Regulations on No Surprises Act’s Independent Dispute Resolution Process and Good Faith Estimate Requirements

Nov 08, 2021

Posted by Sidley Austin

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CMS Proposes to Repeal Device Coverage Pathway and “Reasonable and Necessary” Regulations

Nov 08, 2021

Posted by Sidley Austin

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Pharmacovigilance Considerations in the Era of Patient Centricity: Data Collected by Apps

Nov 08, 2021

Posted by Sidley Austin

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The Lessons of In Re: Boeing for Healthcare and Life Sciences Companies

Nov 08, 2021

Posted by Sidley Austin

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Avid Bioservices Announces Expansion into Viral Vector Development and Manufacturing Services for Cell and Gene Therapy

Nov 04, 2021

Posted by Avid Bioservices, Inc.

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Member Spotlight: Q&A with Karyopharm Therapeutics

Jun 02, 2022

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Statement from MassBio’s Executive Leadership Regarding Supreme Court's Dobbs v. Jackson Decision

Jun 24, 2022

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MassBio leverages its unparalleled network of innovative companies and industry thought leaders to advance policy and promote education, while providing member programs, events, industry information, and services.

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Massachusetts Biotechnology Council

700 Technology Square, 5th Floor
Cambridge, MA 02139
617.674.5100

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