FDA Clarifies ANDA Active Ingredient Sameness Evaluation in Draft Guidance
- On November 8, 2022, FDA issued a draft guidance document on Sameness Evaluations in an ANDA — Active Ingredients (“Draft Guidance”). In the Draft Guidance, FDA indicated that the active ingredient’s chemical form will generally be the entire molecule, but it may also encompass... ›
Prevent a Clinical Trial from Turning Into a Criminal Trial
By: Stacy Cline Amin, 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... ›Germany: Ministry of Health Grants First Glimpse on the Upcoming Cannabis Legalization and Seeks Green Light from the European Commission
By: Robert Grohmann
MoFo research assistant Tim Stripling contributed to this article. In November 2021, in its coalition agreement, the newly elected German Federal Government announced its plans to legalize cannabis for recreational use. Since then, it has been hotly debated by the cannabis industry in Germany... ›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... ›FDA Updates COVID-19 Test Policy
By: Stacy Cline Amin
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... ›FDA Releases Foundational Digital Health Guidance
By: Stacy Cline Amin and Brigid DeCoursey Bondoc
On September 27, 2022, the U.S. Food and Drug Administration (FDA) issued its long-awaited final clinical decision support (CDS) software function guidance. This final guidance presents a significant departure from the previous draft version issued three years prior, including updates to address concerns voiced... ›New Opportunities for Test Developers: Monkeypox Diagnostics
By: Stacy Cline Amin and Brigid DeCoursey Bondoc
For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of testing products. However, test developers must act fast. The Food and Drug Administration is... ›Key Considerations for Early-Stage Companies in the Alternative Protein Industry
By: Simon Arlington, Julia Kotamäki and Michelle Si-Ting Luo
Companies in the UK are regulated by many statutes, ranging from those dictating how much tax they need to pay, to those centred on how they treat their employees. At a corporate level, the main statute that companies should be familiar with is the... ›Purple Tomato Is First Genetically Engineered Plant to Be Deregulated Through USDA’s New Regulatory Status Review Process
By: Liz Freeman Rosenzweig Ph.D.
On September 7, 2022, the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) announced the completion of the first Regulatory Status Review (RSR) of a genetically engineered plant under the SECURE rule. APHIS concluded that a new genetically engineered tomato... ›Recent Biden Administration Efforts on Drug Pricing: USPTO Notice Focuses on Eliminating Inconsistencies in USPTO/FDA Statements
By: Meghan McLean Poon Ph.D., Kelsey J. Roberts Kingman Ph.D. and Stacy Cline Amin
On July 29, 2022, the U.S. Patent and Trademark Office (USPTO) issued a Notice in the Federal Register clarifying the duty of disclosure that may keep patent practitioners up at night. The Notice reminds applicants of the duties of disclosure and “reasonable inquiry” for proceedings... ›