MoFo Life Sciences

January 20, 2023 - Healthcare, United States, Pharma, Litigation, Regulatory
CMS Reveals New Details on Medicare Drug Price Negotiation Program
For the first time in history, the Centers for Medicare and Medicaid Services (CMS) will engage in price negotiations with drug manufacturers for a subset of high-cost, name-brand drugs covered by Medicare. Pursuant to the Inflation Reduction Act (IRA), CMS took its first steps
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December 20, 2022 - European Union, Healthcare, Intellectual Property, Medical Devices + Diagnostics
EU MDR and IVDR Implementation: Signs of Relaxing Transitioning Regime and Bridging Measures
By: Wolfgang Schönig and Robert Grohmann
Concerns over possible medical device shortages in the EU have led to two recent developments that will affect the implementation of the Medical Device Regulation [1] ( MDR ) and In Vitro Diagnostic Medical Device Regulation [2] ( IVDR ) : The EU Employment,
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December 02, 2022 - Healthcare, FDA, Regulatory, Litigation, United States
The USPTO and the FDA Join Hands to Promote Competition
By: Mehran Arjomand and Jean Nguyen Ph.D.
On November 15, 2022, the Berkeley Center for Law and Technology hosted a webinar to address the recent, unprecedented collaboration between the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA). The webinar, entitled “The USPTO‑FDA Collaboration: A Discussion of
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November 29, 2022 - FDA, Healthcare, Digital Health, Regulatory, Pharma, United States
CMS Publishes Final 2023 Medicare Physician Fee Schedule—Key Takeaways for Telehealth Companies
On November 1, 2022, the Centers for Medicare and Medicaid Services (CMS) published the final 2023 Medicare Physician Fee Schedule (“2023 Fee Schedule”). Although the 2023 Fee Schedule most notably sets the rates for Medicare services for the coming year, the rulemaking also traditionally includes
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November 17, 2022 - FDA, Healthcare, Digital Health, Regulatory, Pharma
FDA Clarifies ANDA Active Ingredient Sameness Evaluation in Draft Guidance
By: Brigid DeCoursey Bondoc
On November 8, 2022, FDA issued a draft guidance document on Sameness Evaluations in an ANDA — Active Ingredients (“Draft Guidance”). In the Draft Guidance, FDA indicated that the active ingredient’s chemical form will generally be the entire molecule, but it may also encompass
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November 15, 2022 - FDA, Healthcare, Digital Health, Regulatory
Prevent a Clinical Trial from Turning Into a Criminal Trial
By: Kate Driscoll, Brian K. Kidd and Brian R. Michael
On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and Cybersecurity Challenges in Clinical Trial Enforcement,” during the
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October 28, 2022 - United States, Healthcare, Regulatory, Digital Health, Biotech
U.S. Government Launches Billion-Dollar Biomedical Agency
By: Tina D. Reynolds
As part of the Biden Administration’s ongoing efforts to spur innovation and research, it has championed the creation of a new sub-agency within the Department of Health and Human Services, the Advanced Research Projects Agency for Health (ARPA-H). Authorized by Congress in March 2022, the new
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October 18, 2022 - FDA, Digital Health, Healthcare
Telehealth Fraud Enforcement: Trends, Predictions, and Best Practices
By: Kate Driscoll
Morrison Foerster's Kate Driscoll joined the American Bar Association Health Law Section "Voices in Health Law" podcast to discuss the latest telehealth enforcement trends. The rise of telehealth services during the COVID-19 pandemic resulted in new and adapted forms of fraud, and Kate offers
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September 30, 2022 - United States, Healthcare
A Day Late and a Dollar Short: AAG Polite Warns That Corporate Leaders Who Fail to Invest in Compliance “Early and Often” Do So “At Their Own Risk”
By: Nathaniel R. Mendell, Brian R. Michael, Christine Y. Wong, Kate Driscoll and Mitchell E. Feldman
On September 28, 2022, the Assistant Attorney General for the Criminal Division of the United States Department of Justice (DOJ) joined the Inspector General for the United States Department of Health and Human Services (HHS-OIG) to offer some stern advice for corporate leaders and
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September 28, 2022 - FDA, COVID-19, Healthcare, Medical Devices + Diagnostics, Regulatory, United States
FDA Updates COVID-19 Test Policy
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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Topic Archives: Healthcare

CMS Reveals New Details on Medicare Drug Price Negotiation Program

EU MDR and IVDR Implementation: Signs of Relaxing Transitioning Regime and Bridging Measures

By: Wolfgang Schönig and Robert Grohmann

The USPTO and the FDA Join Hands to Promote Competition

By: Mehran Arjomand and Jean Nguyen Ph.D.

CMS Publishes Final 2023 Medicare Physician Fee Schedule—Key Takeaways for Telehealth Companies

FDA Clarifies ANDA Active Ingredient Sameness Evaluation in Draft Guidance

By: Brigid DeCoursey Bondoc

Prevent a Clinical Trial from Turning Into a Criminal Trial

By: Kate Driscoll, Brian K. Kidd and Brian R. Michael

U.S. Government Launches Billion-Dollar Biomedical Agency

By: Tina D. Reynolds

Telehealth Fraud Enforcement: Trends, Predictions, and Best Practices

By: Kate Driscoll

A Day Late and a Dollar Short: AAG Polite Warns That Corporate Leaders Who Fail to Invest in Compliance “Early and Often” Do So “At Their Own Risk”

By: Nathaniel R. Mendell, Brian R. Michael, Christine Y. Wong, Kate Driscoll and Mitchell E. Feldman

FDA Updates COVID-19 Test Policy