Podcast - California Employment News: The Employment Start-Up Kit for Start-Ups – Part 1
California Employment News: The Employment Start-Up Kit for Start-Ups – Part 1
Nonprofit Basics: Operating Foundation Rules
Primer for Nonprofits on Paid Employees, Volunteers, and Interns
Employment Law This Week®: DOL’s Final Overtime Rule, CA Codifies “ABC Test,” Pay Data Collection Beyond 2018, NLRB’s Busy Summer
Is My New Hire an Employee or a Contractor? Key Factors for Startups to Consider
Employment Law This Week®: Gig Worker Classification, NLRB Rulemaking Agenda, Non-Compete Agreement Backlash
As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations in...more
The Food and Drug Administration (FDA) regulates the marketing of dietary supplements, over-the-counter (OTC) drugs, cosmetics, medical devices, foods, infant formula, pet foods/supplements, and even e-cigarettes. However,...more
Even though they are still quoted, statements in Medtronic v. Lohr, which question whether FDA (Food & Drug Administration) medical device clearance is a judgment about a device’s safety, no longer accurately describe what...more
In vitro diagnostic medical devices (IVDs), hence devices used for medical tests on samples such as blood or tissue that have been taken from the human body, have become the center of attention in the public eye during the...more
Having shed light on the relevance of the intended purpose of a medical device when determining whether software qualifies as medical devices software (“MDSW”) under the new EU Medical Device Regulation 2017/745 (“MDR”) in...more
Since the 21st Century Cures Act became law in December 2016, we have been keeping track of the Food and Drug Administration’s actions to carry out its obligations under the relatively new law. One particular provision of the...more