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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August 29, 2022 - Intellectual Property, Litigation, FDA, Regulatory
Recent Biden Administration Efforts on Drug Pricing: USPTO Notice Focuses on Eliminating Inconsistencies in USPTO/FDA Statements
By: Meghan McLean Poon, Kelsey J. Roberts Kingman and Stacy Cline Amin
On July 29, 2022, the U.S. Patent and Trademark Office (USPTO) issued a Notice in the Federal Register clarifying the duty of disclosure that may keep patent practitioners up at night. The Notice reminds applicants of the duties of disclosure and “reasonable inquiry” for proceedings
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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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April 13, 2022 - FDA, Product Liability + Class Action, Litigation, Regulatory
RULINGS, FDA GUIDANCE MAY HELP FOOD COS. IN PROTEIN SUITS
By: Claudia M. Vetesi, Nicole Victoria Ozeran and Lena Gankin
Originally published by Law360 , Claudia Vetesi, Nicole Ozeran, and Lena Gankin authored an article discussing a wave of protein-labeling lawsuits hitting food manufacturers, alleging that their products’ front-label protein content statements violate U.S. Food and Drug Administration (FDA) regulations, and mislead consumers by overstating the amount
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Topic Archives: FDA

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

Recent Biden Administration Efforts on Drug Pricing: USPTO Notice Focuses on Eliminating Inconsistencies in USPTO/FDA Statements

By: Meghan McLean Poon, Kelsey J. Roberts Kingman and Stacy Cline Amin

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

RULINGS, FDA GUIDANCE MAY HELP FOOD COS. IN PROTEIN SUITS

By: Claudia M. Vetesi, Nicole Victoria Ozeran and Lena Gankin