MoFo Life Sciences

February 03, 2022 - FDA, Medical Devices + Diagnostics, Digital Health, Healthcare, Pharma
MoForum Recap: Transformation Across the Industry
Our recent Life Sciences MoForum included in-depth discussions with industry insiders on the convergence of the life sciences with technology and healthcare and the trends that are driving the industry across the digital health, diagnostic, and drug markets. Digital Transformation in the Life Sciences
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January 27, 2022 - FDA, Biotech, Healthcare, Pharma
FDA OKs Mail-Order Mifepristone: State Laws May Inhibit its Use
By: Rachel Park and Brigid DeCoursey Bondoc
In December 2021, the U.S. Food and Drug Administration announced that it would make permanent its COVID-19-era enforcement policy, which allows for the delivery of the abortion pill (MIFEPREX (mifepristone)) by mail and through telemedicine in order to reduce the burden on patient access.
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January 20, 2022 - FDA, Biotech, Healthcare, Pharma, Regulatory
FDA Releases Draft Guidance on Use of Real-World Evidence for Drug & Biological Products
Bethany Hills and Dan Rubin authored an article for Life Science Connect outlining the U.S. Food and Drug Administration’s (FDA) new draft guidance in its latest effort to clarify its expectations regarding the integration of real-world data and real-world evidence into clinical research, product
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December 23, 2021 - FDA, Medical Devices + Diagnostics, Litigation, Healthcare
3 Key Takeaways from FDLI’s FDA Center Compliance Directors: Presentations and Q&A Session
By: Rachel Park
FDLI hosted a virtual Enforcement, Litigation, and Compliance Conference December 9–10, 2021. The session titled Compliance Central with FDA Center Compliance Directors: Presentations and Q&A addressed FDA’s top compliance issues, enforcement priorities, and goals for 2022. The session included presentations from Ann Oxenham (CFSAN),
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December 23, 2021 - FDA, COVID-19, Healthcare, Pharma
Key Takeaways from FDLI’s Enforcement, Litigation, and Compliance Conference Keynote Address
By: Rachel Park
FDLI hosted a virtual conference December 9–10, 2021. The keynote address was given by Arun Rao, Deputy Assistant Attorney General at the United States Department of Justice (DOJ). Arun Rao discussed the efforts of the Consumer Protection Branch in 2021, and highlighted areas of
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December 22, 2021 - FDA, Healthcare
What New FDA Policy Means for COVID Tests and Beyond
By: Stacy Cline Amin
Stacy Amin and Bethany Hills, co-chairs of our FDA Regulatory + Compliance practice, authored an article for Law360 discussing the U.S. Department of Health and Human Services (HHS) withdrawing a controversial Trump administration policy that prohibited the U.S. Food and Drug Administration (FDA) from requiring
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December 20, 2021 - FDA, Medical Devices + Diagnostics
De Novo Classification Final Rule to Take Effect Next Year
By: Brigid DeCoursey Bondoc
On Tuesday, December 14, 2021, the U.S. Food and Drug Administration (FDA) hosted a webinar discussing the final rule , Medical Device De Novo Classification Process, and associated guidance document updates. The final rule, which will take effect on January 3, 2022, codifies the
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November 30, 2021 - United States, FDA, Healthcare
Rescinding the MCIT/R&N Final Rule, CMS Seeks New Approaches for Innovative Technology Coverage
On November 12, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a final rule rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” final rule (MCIT/R&N). As we reported in an earlier blog post , CMS first proposed
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November 19, 2021 - FDA
HHS Reverses Policy Prohibiting FDA Review of Lab-Developed Tests
By: Stacy Cline Amin and Brigid DeCoursey Bondoc
On November 15, 2021, the Department of Health and Human Services (HHS) announced it would reverse a policy issued in August 2020 prohibiting the Food and Drug Administration (FDA) from requiring a premarket review of laboratory developed tests (“LDTs”), including requiring Emergency Use Authorizations
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November 18, 2021 - AI + Robotics, United States, FDA, Digital Health
Three Key Takeaways from FDLI’s Panel Discussion on FDA’s Digital Health Center of Excellence and Working with the FDA in the Digital Health Space
By: Stacy Cline Amin and Rachel Park
FDLI hosted a virtual conference November 9-10, 2021, titled Digital Health Technology and Regulation During COVID-19 and Beyond. One of the keynote events was the panel on “FDA’s Digital Health Center of Excellence: Working with the FDA on Digital Health.” The panel featured Bakul
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Topic Archives: FDA

MoForum Recap: Transformation Across the Industry

FDA OKs Mail-Order Mifepristone: State Laws May Inhibit its Use

By: Rachel Park and Brigid DeCoursey Bondoc

FDA Releases Draft Guidance on Use of Real-World Evidence for Drug & Biological Products

3 Key Takeaways from FDLI’s FDA Center Compliance Directors: Presentations and Q&A Session

By: Rachel Park

Key Takeaways from FDLI’s Enforcement, Litigation, and Compliance Conference Keynote Address

By: Rachel Park

What New FDA Policy Means for COVID Tests and Beyond

By: Stacy Cline Amin

De Novo Classification Final Rule to Take Effect Next Year

By: Brigid DeCoursey Bondoc

Rescinding the MCIT/R&N Final Rule, CMS Seeks New Approaches for Innovative Technology Coverage

HHS Reverses Policy Prohibiting FDA Review of Lab-Developed Tests

By: Stacy Cline Amin and Brigid DeCoursey Bondoc

Three Key Takeaways from FDLI’s Panel Discussion on FDA’s Digital Health Center of Excellence and Working with the FDA in the Digital Health Space

By: Stacy Cline Amin and Rachel Park