California Employment News: Understanding the Basics of Employee Personnel Files (Featured Podcast)
California Employment News: Understanding the Basics of Employee Personnel Files (Featured)
#WorkforceWednesday: Office Building Guidance, OSHA Steps Up, “Fluctuating Workweek” Rule - Employment Law This Week®
Podcast: Keeping Up with Recent Changes and Trends in Private Fund Regulation
Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership
The Act introduces key reforms to the FDA regulatory framework relating to drugs, biological products, and cosmetics, among others. On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023...more
The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more
On August 31, 2022, Biocon Biologics released a statement regarding three recent on-site FDA inspections of seven manufacturing facilities spanning two sites in Bengaluru, India and one site in Johor, Malaysia. The...more
On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more
The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which expands the scope of the current...more