Category Archives: FDA

Breaking Down FDA’s New Remote Monitoring Strategy

On Wednesday, April 14, 2021, the US Food and Drug Administration (FDA) published a long-awaited final guidance document explaining its policy for conducting remote “evaluations” during COVID-19. According to the guidance, FDA will request and conduct voluntary remote evaluations at (1) facilities where drugs and biologics are manufactured, processed, packed, or held; (2) facilities covered … Continue Reading

New State Genetic Privacy Law Directed at Consumer Genetic Tests

By Allison Fulton and Julia Kadish on April 2, 2021 Posted in Digital Health & Medical Devices, FDA, Legislation

Utah recently signed into law SB 227, creating the Genetic Information Privacy Act (GIPA). The law, which is anticipated to go into effect in May 2021, is aimed at protecting genetic data collected from direct-to-consumer (DTC) genetic testing companies. Companies distributing DTC tests should evaluate their current data privacy policies and practices against the obligations … Continue Reading

Latest Update on FDA’s Software Pre-Cert Pilot Program

By Allison Fulton and Julia Kadish on September 16, 2020 Posted in Digital Health & Medical Devices, FDA

On September 14, 2020, the U.S. Food and Drug Administration (FDA) released an update on the status of its Software Precertification (Pre-Cert) Program. It is the only public update on the program in 2020. According to the update, FDA will continue to evaluate its Pre-Cert program, which currently is only in pilot form. Perhaps disappointing … Continue Reading

FDA Postpones Ex-US Facility Inspections

By Allison Fulton on March 11, 2020 Posted in Coronavirus, Enforcement Actions, FDA

U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn, M.D., announced that FDA is postponing foreign inspections through April 2020 in response to the COVID-19 outbreak. Manufacturers, including contract manufacturers, anticipating post-approval inspections may welcome the news, given other pressing issues facing ex-US facilities (i.e., facilities located outside the US) in light of COVID-19. … Continue Reading

Federal Circuit Revolutionizes Country of Origin Analysis for Pharmaceuticals

By Curtis Dombek on February 11, 2020 Posted in Biotechnology, Enforcement Actions, FDA, Prescription and OTC Drugs

The Federal Circuit Court of Appeals has just rejected the longstanding U.S. government position that the country of origin of pharmaceuticals in the context of U.S. government procurement is determined by where the active pharmaceutical ingredient (API) is made. Acetris Health, LLC v. United States, 2018-2399, judgment of February 10, 2020. In the Acetris case the API was made … Continue Reading

Tips for When to Consider Legal Review of Quality System Investigations

By Allison Fulton on September 23, 2019 Posted in FDA

This post was originally published on MD+DI.com. As a lawyer with extensive experience in good manufacturing practice (GMP) issues, clients will ask me to review complex Quality System investigations. My clients are typically in-house counsel and, while review by Legal makes sense to a company’s in-house counsel (after all they, too, are lawyers), Quality or … Continue Reading

What’s in the Bottle? FDA Announces New Blockchain Pilot Program for Tracking Drug Distribution

By Samuel Gilkeson and John Tilton on July 26, 2019 Posted in FDA

Where does my prescription come from? Has it been altered or diluted? Can I trust the label? With millions of prescriptions filled each year, quality control and security across the pharmaceutical supply chain seems like a herculean task. In an attempt to slay this proverbial hydra, the Food and Drug Administration (FDA) developed a new … Continue Reading

Medical Devices – Artificial Intelligence and Reactions to FDA’s Proposed Oversight

By Allison Fulton on June 25, 2019 Posted in Digital Health & Medical Devices, FDA

In April of this year, the US Food and Drug Administration (FDA) released a discussion paper, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical Device (SaMD), which proposed a novel regulatory framework for artificial intelligence (AI)-based medical devices. The public docket closed on June 3, 2019, and … Continue Reading

FDA Issues Warning Letter to Lab Marketing Three Laboratory-Developed Tests

By Allison Fulton and Kenneth Yood on April 22, 2019 Posted in FDA

In an April 4, 2019 Press Release, the U.S. Food and Drug Administration (FDA) announced its issuance of a Warning Letter to Inova Genomics Laboratory (Inova) in Virginia for marketing genetic tests for predicting medication response and patient receptivity to drugs (among other things). FDA identified three genetic tests, including one called “MediMap Plus,” which … Continue Reading

The Farm Bill’s Impact on Hemp and CBD – and How Some States are Reacting

By Andrea Cataneo on March 12, 2019 Posted in FDA, IP and Technology Transactions, Miscellaneous, Tobacco

While the legal landscape continues to evolve in the cannabis industry, making entry into the space a potentially risky proposition, the passage of the Agriculture Improvement Act of 2018 (the “Farm Bill”) can be a real game changer in attracting mainstream companies to the industry. According to the Farm Bill, hemp is now exempt from … Continue Reading

Proposed New FDA Labeling Rules Would Result in Increased Generic Drug Product Liability Claims

By Bradley Graveline on October 14, 2016 Posted in FDA

After several years of delay, FDA announced this summer that it expects to publish new rules in April 2017 that will permit generic drug companies to make unilateral changes to their warning labels, even if the brand does not. The rule changes, if implemented, would have a significant impact on the potential liability of generic … Continue Reading

Forget About Vermont!: Congress Passes GMO “Labeling” Legislation

By Peter Reichertz on July 19, 2016 Posted in FDA

On July 14, 2016, the House of Representatives passed S.764 creating a National Bioengineered Food Standard. Importantly for food manufacturers and distributors, the law – expected to be signed by President Obama – will preempt all state laws “relating to the labeling or disclosure of whether a food is bioengineered or was developed or produced … Continue Reading

Extending the Patentable Life of 3D Printers: A Lesson From the Pharmaceutical Industry

By Jesse Salen on January 19, 2016 Posted in Biotechnology, FDA, Legislation

Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’ Under U.S. law (and most other jurisdictions), an innovation to an existing technology is patentable so long as at least one claim limitation is novel and non-obvious. … Continue Reading