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 U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more
The COVID-19 pandemic highlighted both the incredible promise and challenges for life science companies developing and manufacturing drugs, biological products, and devices that enhance our lives....more
The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more
Our FDA and Health Care Policy teams discuss how sponsors and manufacturers can prepare for legislative and regulatory changes that could come from the final Food and Drug Amendments (PDUFA VII) and what companies can do...more
Overview - In this month’s post, in the medical device realm I explore what kinds of inspection citations most often precede a warning letter. In this exercise, I do not try to prove causation. I am simply exploring...more
FDA announced on February 2 that it would be resuming domestic surveillance inspections across all product types, beginning on February 7, in light of declining COVID-19 rates. This announcement follows a series of inspection...more
Manufacturing sites should prepare now for inspections before the U.S. Food and Drug Administration (FDA) resumes routine on-site inspections. Since 2020, FDA has delayed many routine inspections due to the pandemic. In...more
It is common for FDA and others to show a map of the United States with the states color-coded by intensity to showcase the total number of inspections done in that state. Indeed, FDA includes such a map in its newly...more
Over the past year and as a result of the COVID-19 pandemic, FDA relied on alternative inspectional tools and approaches, including remote interactive evaluations and record requests, as well as a prioritization scheme, to...more
On April 14, the U.S. Food and Drug Administration (FDA) released the immediately-in-effect guidance “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public...more
The U.S. Food and Drug Administration (FDA) issued an update to its guidance document, “Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers,”...more
The COVID-19 pandemic has resulted in an unprecedented disruption to the U.S. Food and Drug Administration (FDA) inspection program. With the vast majority of its inspectional activities on hold due to the pandemic, FDA has...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time....more
The US Food and Drug Administration (FDA) announced on July 10 that it will resume domestic inspections of regulated facilities and activities using a new risk assessment rating system....more
The pharmaceutical supply chain is extremely complex and relies on manufacturing sites located throughout the world. The COVID-19 pandemic has placed significant strain on this complex system. ...more
Life science companies should consider offering FDA creative solutions for submissions that require pre-approval inspections....more
For-cause inspections will proceed if deemed “mission critical.” The US Food and Drug Administration (FDA) had previously announced on March 10 that routine foreign inspections were suspended. FDA suggests that it may attempt...more
With the increasing numbers of coronavirus (COVID-19) cases and the declaration of a global pandemic by the World Health Organization, the pharmaceutical and biotech industries are assessing how this situation may impact...more
The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more