MoFo Life Sciences

September 28, 2022 - FDA, COVID-19, Healthcare, Medical Devices + Diagnostics, Regulatory, United States
FDA Updates COVID-19 Test Policy
By: Stacy Cline Amin
Brandy Guarda, Regulatory Analyst in Washington, D.C., contributed to the drafting of this post. On September 27, 2022, the U.S. Food and Drug Administration (FDA) updated its COVID-19 Test Policy Guidance to encourage test developers to pursue full marketing authorization as opposed to Emergency
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September 28, 2022 - FDA, Healthcare, Medical Devices + Diagnostics, Regulatory, United States
FDA Releases Foundational Digital Health Guidance
By: Stacy Cline Amin, Brigid DeCoursey Bondoc and Rachel Park
On September 27, 2022, the U.S. Food and Drug Administration (FDA) issued its long-awaited final clinical decision support (CDS) software function guidance. This final guidance presents a significant departure from the previous draft version issued three years prior, including updates to address concerns voiced
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September 23, 2022 - Healthcare, FDA, Regulatory, Medical Devices + Diagnostics, United States
New Opportunities for Test Developers: Monkeypox Diagnostics
By: Stacy Cline Amin and Brigid DeCoursey Bondoc
For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of testing products. However, test developers must act fast. The Food and Drug Administration is
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June 13, 2022 - Global, FDA, Medical Devices + Diagnostics, Healthcare, Regulatory
EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 3 OF 3)
By: Wolfgang Schönig and Robert Grohmann
Research assistant Nicole Gebert contributed to this article. Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system, conformity assessments, and
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June 06, 2022 - FDA, COVID-19, Healthcare, Regulatory
FDA Will Once Again Accept Pre-Submissions for All In Vitro Diagnostic Tests
By: Stacy Cline Amin and Rachel Park
Lindy Pittman, Summer Associate in Washington, D.C., contributed to the drafting of this post. The U.S. Food and Drug Administration (FDA) released a statement on May 31, 2022, that its Center for Devices and Radiological Health (CDRH) will once again be accepting all pre-submissions
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June 06, 2022 - Global, FDA, Medical Devices + Diagnostics, Healthcare, Regulatory
EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 2 OF 3)
By: Wolfgang Schönig and Robert Grohmann
Research assistant Nicole Gebert contributed to this article. After having discussed the general purpose and background of the IVDR, the new definition of IVDs, and the conformity assessment in light of the new risk classification as well as the role of notified bodies in
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May 31, 2022 - Global, FDA, Medical Devices + Diagnostics, Healthcare, Regulatory
EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 1 OF 3)
By: Wolfgang Schönig and Robert Grohmann
Research assistant Nicole Gebert contributed to this article. In vitro diagnostic medical devices (IVDs), hence devices used for medical tests on samples such as blood or tissue that have been taken from the human body, have become the center of attention in the public
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May 26, 2022 - United States, FDA, Healthcare, Pharma, Regulatory, Intellectual Property
Senators Call for Report on State of Psychedelic Research
By: Stacy Cline Amin
Thanks to our Life Sciences Transactions + Licensing Group, including Matthew Karlyn, Mai Zymaris, and Hannah Koo, for contributing to this post. Earlier this month, Senators Brian Schatz (D-HI) and Cory Booker (D-NJ) sent a letter to the National Institutes of Health (NIH) and
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May 12, 2022 - United States, Biotech, Healthcare, Intellectual Property
The “Big Bang” for Sequence Listings: New Requirements in Place July 1, 2022
By: Liz Newman and Karen G Potter
Life sciences patent applications often contain DNA, RNA, and amino acid sequences in the specification, claims, or figures that are required to be provided in the form of a sequence listing. The inclusion of sequences in patent applications are compulsory to satisfy patent office
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April 07, 2022 - United States, FDA, Healthcare, Regulatory
FDA Issues Draft Guidance on Human Gene Therapy Products Incorporating Human Genome Editing
By: Brigid DeCoursey Bondoc and Rachel Park
On March 14, 2022, U.S. Food and Drug Administration (FDA) issued two draft guidances: “ Human Gene Therapy Products Incorporating Human Genome Editing (GE)” and a draft guidance on Chimeric Antigen Receptor (CAR) T cell product development. These draft guidance documents were issued on
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Topic Archives: Healthcare

FDA Updates COVID-19 Test Policy

By: Stacy Cline Amin

FDA Releases Foundational Digital Health Guidance

By: Stacy Cline Amin, Brigid DeCoursey Bondoc and Rachel Park

New Opportunities for Test Developers: Monkeypox Diagnostics

By: Stacy Cline Amin and Brigid DeCoursey Bondoc

EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 3 OF 3)

By: Wolfgang Schönig and Robert Grohmann

FDA Will Once Again Accept Pre-Submissions for All In Vitro Diagnostic Tests

By: Stacy Cline Amin and Rachel Park

EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 2 OF 3)

By: Wolfgang Schönig and Robert Grohmann

EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 1 OF 3)

By: Wolfgang Schönig and Robert Grohmann

Senators Call for Report on State of Psychedelic Research

By: Stacy Cline Amin

The “Big Bang” for Sequence Listings: New Requirements in Place July 1, 2022

By: Liz Newman and Karen G Potter

FDA Issues Draft Guidance on Human Gene Therapy Products Incorporating Human Genome Editing

By: Brigid DeCoursey Bondoc and Rachel Park