MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.
FDA Finalizes Guidance on Interpretation of Orphan Drug “Sameness” for Gene Therapy Products
On September 30, 2021, the U.S. Food and Drug Administration (FDA) announced final guidance titled “Interpreting Sameness of Gene Therapy Products under the Orp
European Union Adopts Regulation to Extend Term of Community Plant Variety Rights in Europe for Varieties of Certain Plant Species
10/27/2021 Update: The adopted regulation ((EU) 2021/1873) is now officially published in the Journal of the EU. In accordance with the vote of the Council of t
Skinny Labels Back in Focus after HHS Report on Addressing Drug Prices
Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated report
Health App and Device Providers Take Note: Health Breach Notification Rule Enforcement Is Coming
As the mobile health and connected device market continues to grow at an exponential pace, the Federal Trade Commission (“FTC”) has issued a Policy Statement th
CMS Proposes to Repeal MCIT Final Rule
Jianyuan (Yuan) Hua, FDA Regulatory and Compliance Associate in New York, contributed to the drafting of this post. Last week, the Centers for Medicare and Medi
Is the Future of Telehealth in OIG’s Hands?
Telehealth services may be at a crossroads. While the COVID-19 pandemic brought about widespread adoption of telehealth services, the Department of Justice and
Cures 2.0: Will It Be Better Than the Original?
It’s summer blockbuster season and that means sequels abound. Now it seems that the U.S. Congress wants in on the action. Just five years after Congress passe
BIDEN ADMINISTRATION Executive Order on Promoting Competition in the American Economy: Drug Pricing and Healthcare Industry Initiatives
On July 9, 2021, President Biden enacted a sweeping executive order creating a “whole‑of-government competition policy.” Morrison & Foerster outlined the admini
EUAs and the FDA’s Fight Against COVID-19: An Evolving Landscape
Christine Lentz, a Morrison & Foerster summer associate in our San Diego office, contributed to the writing of this article. The outbreak of the COVID-19 pandem
The European Commission’s Take on Novel Genomic Techniques (NGTs) in Light of CJEU’s Ruling in Case C-528/16
Summary The decision of the Court of Justice of the European Union (CJEU) in case C-528/16 essentially banning novel genomic techniques (NGTs), in