MoFo Life Sciences

June 07, 2024 - Pharma, FDA
Federal Court Invalidates Dosing Patent Based on Clinical Trials Disclosure
By: Ashley E. Sperbeck and Mark D. McBriar Ph.D.
As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in their overall patent strategy. Disclosure of a protocol summary of the
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March 15, 2024 - FDA
New Plants, Old Frameworks: FDA’s 1992 Policy Applies to Foods Derived from Genome-Edited Plants
By: Brigid DeCoursey Bondoc, Liz Freeman Rosenzweig Ph.D. and Owen Grayson Hosseinzadeh
On February 22, 2024, FDA released a final guidance [1] detailing how foods derived from genome-edited plants fall into FDA’s existing food safety framework and outlining two voluntary consultation processes for developers. The new guidance applies FDA’s 1992 policy regarding Foods Derived from New Plant
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February 07, 2024 - United States, Regulatory, Antitrust, FDA
2024 Regulatory, Compliance, and Enforcement Predictions for Life Sciences Companies
By: Adam L. Braverman, Kate Driscoll, Nathaniel R. Mendell and Brigid DeCoursey Bondoc
The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance and Enforcement Group for a 2024 preview, and here is
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February 07, 2024 - FDA
FTC Alleges Improper Orange Book Listing of Drug Delivery Device Patents
By: Lisa N. Silverman Ph.D., Brigid DeCoursey Bondoc, David J. Shaw and Qiwen Zhong Ph.D.
In the latest attempt to promote generic drug competition and reduce drug prices, and consistent with broader efforts to enforce the antitrust laws more aggressively, the Federal Trade Commission (FTC) announced on November 7, 2023, challenges to more than 100 patent listings by brand
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February 07, 2024 - United States, FDA
FDA's Lab-Developed Test Rule May Bring Historic Challenges
At the end of September, the U.S. Food and Drug Administration released a proposed rule that sounds mundane — its plan to regulate laboratory-developed tests — but was the administrative law equivalent of Taylor Swift announcing her Eras tour. Read the full blog.
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December 04, 2023 - United States, FDA
Comment on Morphing U.S. Biotechnology Regulations
By: Michael Ward Ph.D., Brigid DeCoursey Bondoc, Liz Freeman Rosenzweig Ph.D. and Owen Grayson Hosseinzadeh
The U.S. Department of Agriculture (USDA) and U.S. Patent and Trademark Office (USPTO) have recently opened requests for stakeholder engagement regarding biotechnology regulatory frameworks. These requests provide the opportunity to influence government policy regarding federal and international biotechnology regulations that will affect anyone sourcing
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October 25, 2023 - FDA, United States
Golden State Crackdown—Unpacking California’s Landmark Food Safety Act
By: Claudia M. Vetesi, Brigid DeCoursey Bondoc, Lena Gankin and Marcus Grimes
Update: On November 2, FDA issued a proposed rule to revoke the regulation authorizing the use of brominated vegetable oil (BVO) in food. FDA is basing the proposed rule on studies it conducted that FDA says demonstrate adverse health effects in animals approximating real-world human
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October 24, 2023 - FDA, Healthcare
New FDA Guidance on COVID-19 Vaccines
By: Brigid DeCoursey Bondoc
Last week, the U.S. Food and Drug Administration (FDA) published its new guidance on the Development and Licensure of Vaccines to Prevent COVID-19 (the “Guidance”). FDA provided a preview of a new COVID-19 vaccines guidance back in March 2023 , when it announced that
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October 11, 2023 - FDA
FDA Issues New Draft Guidance on Demonstrating Substantial Evidence of Effectiveness with One Clinical Investigation and Confirmatory Evidence
By: Brigid DeCoursey Bondoc
On September 19, FDA released a highly anticipated new draft guidance for industry titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence. The draft guidance expands on Section 115 of the Food and Drug Administration Modernization
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August 08, 2023 - FDA, Pharma, United States, Healthcare
Medicare Drug Price Negotiation Program Final Guidance
Elena Klonoski, a summer associate in our Boston office, and Lauren Limbach, a summer associate in our Washington, D.C. office, contributed to the drafting of this post. 1. Introduction On June 30, 2023, the Centers for Medicare and Medicaid Services (CMS) released its much-anticipated
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Topic Archives: FDA

Federal Court Invalidates Dosing Patent Based on Clinical Trials Disclosure

By: Ashley E. Sperbeck and Mark D. McBriar Ph.D.

New Plants, Old Frameworks: FDA’s 1992 Policy Applies to Foods Derived from Genome-Edited Plants

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

2024 Regulatory, Compliance, and Enforcement Predictions for Life Sciences Companies

By: Adam L. Braverman, Kate Driscoll, Nathaniel R. Mendell and Brigid DeCoursey Bondoc

FTC Alleges Improper Orange Book Listing of Drug Delivery Device Patents

By: Lisa N. Silverman Ph.D., Brigid DeCoursey Bondoc, David J. Shaw and Qiwen Zhong Ph.D.

FDA's Lab-Developed Test Rule May Bring Historic Challenges

Comment on Morphing U.S. Biotechnology Regulations

By: Michael Ward Ph.D., Brigid DeCoursey Bondoc, Liz Freeman Rosenzweig Ph.D. and Owen Grayson Hosseinzadeh

Golden State Crackdown—Unpacking California’s Landmark Food Safety Act

By: Claudia M. Vetesi, Brigid DeCoursey Bondoc, Lena Gankin and Marcus Grimes

New FDA Guidance on COVID-19 Vaccines

By: Brigid DeCoursey Bondoc

FDA Issues New Draft Guidance on Demonstrating Substantial Evidence of Effectiveness with One Clinical Investigation and Confirmatory Evidence

By: Brigid DeCoursey Bondoc

Medicare Drug Price Negotiation Program Final Guidance