Category Archives: FDA

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

Allison FultonJulia KadishBy Allison Fulton and Julia Kadish on 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

Allison FultonBy Allison Fulton on 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

Curtis DombekBy Curtis Dombek on 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

Allison FultonBy Allison Fulton on 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

Samuel GilkesonJohn TiltonBy Samuel Gilkeson and John Tilton on 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

Allison FultonBy Allison Fulton on 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

Allison FultonKenneth YoodBy Allison Fulton and Kenneth Yood on 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

Andrea CataneoBy Andrea Cataneo on 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

Bradley GravelineBy Bradley Graveline on 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

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

Jesse SalenBy Jesse Salen on 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
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