MoFo Life Sciences

March 02, 2021 - COVID-19, United Kingdom, European Union, Healthcare, Pharma
COVID-19: State Intervention in Times of Vaccine Shortages
By: Robert Grohmann
The European Union (“EU”) and its Member States are struggling with the pace of their vaccination programs. This is partly due to shortages of vaccine availability. Germany, like the rest of the EU, is scrambling to obtain vaccine doses as the pharmaceutical industry slows
... ›
March 01, 2021 - FDA, COVID-19, Rare Disease, Biotech, Healthcare, Pharma, Regulatory
Rare Disease: Sustained Progress in Development Regardless of the Pandemic
By: Catherine M. Polizzi
Sunday, February 28, 2021, was Rare Disease Day. With so much focus on COVID-19 throughout 2020, it’s important to recognize the continued work done in rare disease drug development by sponsors and FDA throughout 2020. In addition, a number of policies implemented in response
... ›
February 26, 2021 - COVID-19, Litigation, Healthcare
Do You Have the COVID-19 Blues? Don’t Forget About Sunshine!
While the Centers for Medicare and Medicaid Services (CMS) acknowledges the impact COVID-19 has had on the healthcare industry, CMS does not have the authority to postpone the deadline for Sunshine Act reporting. Accordingly, March 31, 2021, remains the deadline for reporting for 2020.
... ›
February 24, 2021 - Medical Devices + Diagnostics, United Kingdom, Healthcare, Pharma, Regulatory
Life Sciences Regulatory Framework Becomes Law Post-Brexit
By: Gareth Rees KC and Jenny Galloway
Nearly one year after its introduction to the House of Commons, the Medicines and Medical Devices Bill 2019‑2021 (the Bill) was granted Royal Assent on 11 February 2021, becoming law as the Medicines and Medical Devices Act 2021 (the Act). The purpose of the Act is
... ›
November 18, 2020 - European Union, Healthcare, Regulatory, Privacy + Data Security
Health Data Made in France- Is France Moving Towards a Sovereign Cloud Requirement for Health Data?
By: Alex van der Wolk
Since the decision of the European Court of Justice (“ECJ”) in the Schrems II case, transfers of personal data from the EU to the United States have been under scrutiny. The ECJ reviewed the situation where personal data are sent from an EU affiliate to its
... ›
November 17, 2020 - United States, FDA, Healthcare
Recent Digital Health-Related FDA Announcements
By: Jean Nguyen
The U.S. Food and Drug Administration (FDA) is showing its dedication to the advancement of digital health technology with two recent announcements: a new Digital Health Center of Excellence and an update on its Software Precertification Program. Manufacturers developing mobile medical devices, software as
... ›
November 13, 2020 - Medical Devices + Diagnostics, United Kingdom, Healthcare, Pharma, Regulatory
UK Plans for Robust Life Sciences Regulation Post-Brexit
By: Gareth Rees KC and Wolfgang Schönig
As Brexit is finally completed in the UK, from 1 January 2021, the Medicines and Healthcare products Regulatory Agency (“MHRA”) will be the UK’s standalone medicines and medical devices regulator. Transition from the EU allows the UK to offer fully independent regulatory decisions for
... ›
September 18, 2020 - United States, FDA, COVID-19, Product Liability + Class Action, Healthcare
First Decisions Limit PREP Act Immunity in Coronavirus Context
By: Erin M. Bosman and Julie Y. Park
When we discussed the Public Readiness and Emergency Preparedness (PREP) Act earlier this year, we predicted that its tort liability protections would reassure manufacturers and distributors of novel COVID-19 drugs and medical products. So far, so good: the first court decisions interpreting PREP Act
... ›
September 09, 2020 - United States, FDA, Biotech, Healthcare, Pharma, Intellectual Property, Cell + Gene Therapy
Pediatric Exclusivity for Biologics
The U.S. Food and Drug Administration’s six-month pediatric exclusivity rules that apply to drugs also largely apply to biologics (albeit with certain distinctions), which may become a valuable life cycle management strategy for biopharmaceutical companies (hereinafter “Sponsors”) in addition to patent exclusionary rights. At
... ›
June 02, 2020 - United States, Healthcare, Privacy + Data Security
FTC Seeks Comments on Health Breach Notification Rule
By: Melissa M. Crespo
The Federal Trade Commission (FTC) recently announced a review and open comment period for the Health Breach Notification Rule, 16 C.F.R. Part 318 (the “Rule”), which requires vendors of personal health records (PHR) and related entities that aren’t covered by HIPAA to provide notice
... ›