MoFo Life Sciences

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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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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April 01, 2022 - FDA, Medical Devices + Diagnostics, Healthcare, Regulatory
QMSR: Welcomed by the Industry, but Lacking in Practicality
By: Brigid DeCoursey Bondoc and Rachel Park
On March 2, 2022, FDA hosted a public Device Good Manufacturing Practice Advisory Committee meeting, where the Committee discussed the proposed rule titled "Medical Devices: Quality System Regulation Amendments." If finalized, the proposed rule will rename the current 21 CFR Part 820 as the
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March 22, 2022 - FDA, Agtech, Regulatory
FDA Clears CRISPR-Edited Cattle for Market Through Abbreviated Procedure: A First for Food-Use Animals
By: Brigid DeCoursey Bondoc, Liz Freeman Rosenzweig and Owen Grayson Hosseinzadeh
Owen Grayson Hosseinzadeh, Law Clerk in San Diego, contributed to the drafting of this post. On March 7, 2022, the Center for Veterinary Medicine (CVM) of the U.S. Food and Drug Administration (FDA) determined that Acceligen Inc. ’s genome-edited, heat-tolerant cattle, pose a “low
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March 14, 2022 - United States, Healthcare, Pharma, Regulatory
New Jersey Court Affirms Prohibition of Physician Practice from Opening and Operating In-Office Pharmacy
By: Rachel Park
At the end of 2021, the Superior Court of New Jersey, Appellate Division upheld the decision by the New Jersey Board of Pharmacy (the “Board”) denying the application from a New Jersey oncology practice (the “Petitioner”) to register, open, and operate a pharmacy within
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Topic Archives: Regulatory

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

FDA Issues Draft Guidance on Human Gene Therapy Products Incorporating Human Genome Editing

By: Brigid DeCoursey Bondoc and Rachel Park

QMSR: Welcomed by the Industry, but Lacking in Practicality

By: Brigid DeCoursey Bondoc and Rachel Park

FDA Clears CRISPR-Edited Cattle for Market Through Abbreviated Procedure: A First for Food-Use Animals

By: Brigid DeCoursey Bondoc, Liz Freeman Rosenzweig and Owen Grayson Hosseinzadeh

New Jersey Court Affirms Prohibition of Physician Practice from Opening and Operating In-Office Pharmacy

By: Rachel Park