Class Dismissed

March 24, 2020 - Coronavirus (COVID-19), FDA, Pharmaceutical & Medical Devices
FDA Calls “All Hands on Deck” to Keep Hand Sanitizer Stocked
By: Erin M. Bosman and Julie Y. Park
Last week, the U.S. Food and Drug Administration (FDA) took yet another step to encourage production of basic medical supplies in the battle against COVID-19. On Friday, March 20, FDA published two new guidance documents communicating its policy on the manufacture of certain alcohol-based
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March 23, 2020 - Coronavirus (COVID-19), FDA, Product Liability, Pharmaceutical & Medical Devices
PREP Act Declaration Emboldens Drug and Device Industry to Innovate in the Face of a Growing Crisis
By: Erin M. Bosman and Julie Y. Park
COVID-19 is, quite literally, putting the medical supply industry to the test. Manufacturers are being pushed to develop novel products like therapies and vaccines to combat the disease as quickly as possible. The Public Readiness and Emergency Preparedness (PREP) Act encourages drug and medical
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March 17, 2020 - Coronavirus (COVID-19), FDA, Consumer Products
FDA and FTC Send Warning Letters to Companies Marketing Products to Treat Coronavirus; State Attorneys General Follow Suit
By: Erin M. Bosman and Julie Y. Park
The rapid spread of coronavirus has spawned prolific marketing claims that any number of products can treat or prevent coronavirus. It comes as no surprise then that the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) recently issued their first round of
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January 16, 2020 - FDA
2020 Under Dr. Stephen Hahn, FDA’s New Commissioner
By: Julie Y. Park
Last month, Dr. Stephen Hahn was officially sworn in as the new commissioner of the U.S. Food and Drug Administration (FDA). The Senate confirmed him by a 73-17 vote. Hahn became the fourth leader of FDA in 2019 and the first confirmed nominee since
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July 03, 2019 - FDA, Drug & Medical Device, Product Liability, Pharmaceutical & Medical Devices
Committed to Clarity: FDA’s Dedication to Transparency with the End of ASR
By: Erin M. Bosman and Julie Y. Park
On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device reporting.” This report describes updates to FDA’s Medical Device Reporting (MDR) Program, namely the conclusion of the Alternative Summary Reporting (ASR) Program.
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June 05, 2019 - Appellate & Supreme Court, FDA, Product Liability, Pharmaceutical & Medical Devices
Supreme Court Decides Prescription Drug Preemption Case in Favor of Drug Manufacturer
By: Erin M. Bosman and Julie Y. Park
The United States Supreme Court finally clarified its 11-year-old “clear evidence” standard for pharmaceutical preemption. In its much-anticipated opinion delivered by Justice Breyer, the Court unanimously reversed the Third Circuit’s holding that questions of pharmaceutical preemption should be decided by juries. Merck Sharp &
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October 24, 2018 - Privacy, FDA, Drug & Medical Device, Product Liability, Consumer Products
FDA Announces New Efforts to Combat Cybersecurity Threats in Medical Devices
By: Erin M. Bosman and Julie Y. Park
FDA is tackling cybersecurity threats head-on and expects industry to do the same. Earlier this month, FDA commissioner Scott Gottlieb, M.D., announced a series of developments designed to keep pace with evolving cybersecurity threats to medical devices. Industry should take note, as these developments
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September 18, 2018 - Class Certification, FDA, Food Misbranding, Consumer Products, Class Action, Retail
Mixed Results on Class Certification for “Cereal” Plaintiff
In Hadley v. Kellogg Sales Company , Plaintiff Stephen Hadley, who has filed at least two additional lawsuits alleging the mislabeling of breakfast foods, sought certification of four California subclasses of purchasers of Kellogg’s cereal and cereal bar products. On August 17, 2018, Judge
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January 16, 2018 - FDA, Drug & Medical Device, Product Liability
3D Printing Meets Medical Devices: FDA Weighs In On Additive Manufacturing
By: Erin M. Bosman and Julie Y. Park
In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices. The guidance represents FDA’s efforts to provide regulatory direction about additive manufacturing (AM)—the broad field of 3D printing—of medical devices. Specifically, AM makes objects by
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January 03, 2018 - FDA, Consumer Products, Retail
Makeup Shake Up: Potential New Federal Cosmetics Regulations
By: Erin M. Bosman and Julie Y. Park
“Make fine lines and wrinkles disappear!” “Reduce the visibility of fine lines and wrinkles!” At first read, these claims sound one in the same. But for decades, a slight difference in phrasing of cosmetics claims—created as a function of current cosmetics regulations—has been responsible
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Topic Archives: FDA

FDA Calls “All Hands on Deck” to Keep Hand Sanitizer Stocked

By: Erin M. Bosman and Julie Y. Park

PREP Act Declaration Emboldens Drug and Device Industry to Innovate in the Face of a Growing Crisis

By: Erin M. Bosman and Julie Y. Park

FDA and FTC Send Warning Letters to Companies Marketing Products to Treat Coronavirus; State Attorneys General Follow Suit

By: Erin M. Bosman and Julie Y. Park

2020 Under Dr. Stephen Hahn, FDA’s New Commissioner

By: Julie Y. Park

Committed to Clarity: FDA’s Dedication to Transparency with the End of ASR

By: Erin M. Bosman and Julie Y. Park

Supreme Court Decides Prescription Drug Preemption Case in Favor of Drug Manufacturer

By: Erin M. Bosman and Julie Y. Park

FDA Announces New Efforts to Combat Cybersecurity Threats in Medical Devices

By: Erin M. Bosman and Julie Y. Park

Mixed Results on Class Certification for “Cereal” Plaintiff

3D Printing Meets Medical Devices: FDA Weighs In On Additive Manufacturing

By: Erin M. Bosman and Julie Y. Park

Makeup Shake Up: Potential New Federal Cosmetics Regulations

By: Erin M. Bosman and Julie Y. Park