Category Archives: Products Liability

To Ask, or Not to Ask, That is the Question: FDA Guidance on Nonbinding Feedback After Certain Inspections of Device Establishments

By Rachael E. Hunt — FDA recently issued a draft guidance document, Nonbinding Feedback After Certain FDA Inspections of Device Establishments, which outlines the process for obtaining FDA feedback on proposed remedial actions in response to observations issued on a Form 483, the Agency’s Inspectional Observations Form, following an inspection. Background Section 702 of the FDA Reauthorization Act of 2017 (FDARA) amended the Federal Food, Drug, and Cosmetic Act (FDCA) to require FDA to provide nonbinding feedback in certain circumstances after an FDA inspection of a device establishment.  Specifically, FDCA section 704(h)(2) states: (A) The Secretary shall, with respect to a request described in subparagraph (B), provide nonbinding feedback with respect to such request not later than 45 days after the Secretary receives such request. (B) A request described in this subparagraph is a request for feedback— (i) that is made by the owner, operator, or agent….. To continue reading this legal news please click Read full information...

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University Bribery Scandal Gives Life to Rejected Students’ Lawsuits

While corruption seems apparent, experts aren't sure whether the lawsuit can pass a "laugh test.".. To continue reading this legal news please click Read full information...

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How to Minimize Distracted Driving with Children

Distracted driving is a bad habit for many travelers. It seems like we never take enough time to prepare for our activities. Operating a vehicle with other things occupying your focus or your mind is bad enough. What’s even worse is driving in a distracted state with children. Springer & Lyle has experience dealing with personal injury cases due to distracted driving. From what we’ve observed, here are some tips to avoid driving distracted with children. Prepare for your Day Before Getting in the Vehicle The car is not the place to hand out breakfast, review homework, or style your children’s hair. Between the night before and that morning, you must make time to take care of things that require your focus. Even if you’re not looking away, taking your hands from the wheel or focusing on other activities is still distracted driving. Avoid activities you should do at home. Never Take your Eyes Off the Road Many drivers are guilty of turning….. To continue reading this legal news please click Read full information...

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Elko, Nevada: The Grille At Gold Dust West Salmonella Outbreak

A food poisoning outbreak has hit the small Nevada town of Elko this week. Here is what you need to know about the The Grille At Gold Dust West Salmonella Outbreak: According to the recent media coverage, the local health department has identified 17 suspected cases of Salmonella linked to the restaurant. These cases have been reported in Elko, Nevada this week, according to a representative at the Nevada Department of Health and Human Services. The representative for the health agency, Public Information Officer Martha Framsted, confirmed in an email to the press that: “The Grille at Gold Dust West is the suspected source of the disease… The Division staff have been onsite at the facility since Monday, March 11.The business has not been closed and is cooperating with the investigation. This is an ongoing investigation and I will provide additional information as the investigation proceeds.” The Usual Suspects? Based on a recent media interview, it….. To continue reading this legal news please click Read full information...

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Crash on Atlantic Boulevard Causes Minor Injuries

2 Vehicles Involved in Los Angeles Accident Los Angeles, CA (March 14, 2019) – A crash in Los Angeles has led to minor injuries. The accident occurred on the evening […] The post Crash on Atlantic Boulevard Causes Minor Injuries appeared first on Nadrich & Cohen, LLP... To continue reading this legal news please click Read full information...

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