Search Results: Health Care

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Drug Development Scorecard — A Guide for Companies Navigating the FDA Drug and Biologic Development and Approval Process

Developing a new drug or biologic is a complex process. Based on our extensive experience advising early-stage and clinical-stage companies, the Goodwin FDA team created this “scorecard” for companies to use as a guide as they navigate the FDA drug development and approval process. The drug development scorecard (or checklist)…

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Disrupt + Innovate + Transform: Key Regulatory Issues for Digital Health Companies Webinar

Goodwin Life Sciences and Healthcare partner Roger Cohen and associate Anne Brendel along with Life Sciences and FDA associate Steven Tjoe kicked off Goodwin’s multi-part webinar series “Disrupt + Innovate + Transform: A Healthcare Webinar Series” with “Key Regulatory Issues for Digital Health Companies” discussing the key regulatory issues affecting…

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EDPB Clarifies Scientific Research GDPR Compliance; Key Questions for US Sponsors Remain

Last month, the European Data Protection Board (“EDPB”) issued additional guidance on the application of the General Data Protection Regulation (“GDPR”) in the area of scientific health research. You can read our summary of the key takeaways here. While the EDPB’s responses offer some clarifications, many obstacles and complications remain…

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2020 Year in Review: Securities Litigation Against Life Sciences and Healthcare Companies

Despite the turmoil and disruption of 2020, plaintiffs’ lawyers and courts appear to have adapted readily to our “new normal.” Although at lower rates than previous years, plaintiffs’ firms continued to file securities class actions against publicly traded pharmaceutical, biotechnology, medical device and healthcare product and services companies in 2020,…

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Goodwin's Clinical Trials Service Offering

    Given the breadth of clinical-stage companies that the Goodwin FDA and Healthcare teams advise, our regulatory attorneys together with our commercial contracting, products liability and insurance attorneys play an integral role in counseling clinical-stage companies on matters related to the conduct of clinical trials. Learn more about our…

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Moving from the Informed Consent to Approved Labeling: Preparing for Risks in Product Marketing & Use Webinar Recording

On February 3, 2021 Goodwin FDA Regulatory partner, Julie Tibbets, Products Litigation + Counseling partner, Nilda Isidro, and Risk Management & Insurance counsel Brian Mukherjee discussed what drug and biologic companies with late-stage product candidates can do to best position their products to mitigate the risks that come with transitioning from clinical trials to…

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FDA Issues Guidance for Cell and Gene Therapy Manufacturers to Minimize Potential Transmission of SARS-CoV-2

On January 19, 2021, the FDA issued guidance for licensed and investigational cellular and gene therapy (CGT) manufacturers during the COVID-19 pandemic. This new guidance supplements the recommendations provided in FDA’s June 2020 guidance regarding manufacturing controls to prevent contamination in drugs, risk assessment of SARS-CoV-2 as it relates to…

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Highlights for SaMD Developers: FDA’s January 2021 Artificial Intelligence/Machine Learning Action Plan

On January 12, 2021, the U.S. Food and Drug Administration (FDA) published its Action Plan for further development of the Agency’s framework for regulatory oversight of artificial intelligence (AI) and machine learning (ML) based Software as a Medical Device (SaMD).  The Action Plan identifies several opportunities for SaMD developers to…

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FDA Announces Temporary Review Timelines for Responses to Facility Assessment-Related Complete Response Letters Due to COVID-19

As follow-up to our October post on pre-approval and pre-licensure inspections impacting U.S. Food and Drug Administration (FDA) drug and biologic approvals, this blog post discusses FDA’s recently announced temporary policy set forth in its December 2020 guidance on review timelines for company responses to a Complete Response letter (CRL)…

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