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 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The U.S. Food and Drug Administration (FDA or Agency) recently announced the availability of a new draft guidance titled “Conducting Remote Regulatory Assessments: Questions and Answers” (RRA Draft Guidance). Remote...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
On May 5, 2021, the U.S. Food and Drug Administration (FDA) issued a much-anticipated report, “Resiliency Roadmap for FDA Inspectional Oversight,” which provides a roadmap for the agency’s post-pandemic plans to return to a...more
On Wednesday, April 14, 2021, the US Food and Drug Administration (FDA) published a long-awaited final guidance document explaining its policy for conducting remote “evaluations” during COVID-19. According to the guidance,...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
Revance Therapeutics, Inc. recently announced that, because of COVID-19 travel restrictions, the FDA has been unable to complete its inspection of the manufacturing facility for Revance’s DaxibotulinumtoxinA for Injection...more
It has been almost seven months since the Secretary of the Department of Health and Human Services (HHS) declared a public health emergency on January 31, 2020 due to the Coronavirus Disease 2019 (COVID-19). The Food and...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
On July 10, 2020, Commissioner Hahn of the U.S. Food and Drug Administration (FDA) issued a statement announcing that the agency is planning to resume on-site inspections of domestic facilities during the week of July 20. The...more
On July 10, 2020, the U.S. Food and Drug Administration (FDA) announced that it will be restarting on-site prioritized domestic inspections, including food facilities, during the week of July 20 after pausing such inspections...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
The U.S. Food and Drug Administration (FDA) recently provided an update regarding its plans for conducting routine surveillance inspections of domestic and foreign facilities during the COVID-19 pandemic. FDA announced in...more
The U.S. Food and Drug Administration (FDA) announced updated plans for conducting routine inspections of domestic and foreign inspections during the COVID-19 public health emergency. In March, FDA announced that it was...more
In an unprecedented time amid the global COVID-19 pandemic, an increasing number of pharmaceutical manufacturers and developers of active pharmaceutical ingredients are involved in the potentially life-saving development of...more
In response to the COVID-19 outbreak, the U.S. Food and Drug Administration (FDA) has announced it will begin requesting that importers send the agency records required under the Foreign Supplier Verification Programs (FSVP)...more
Our FDA Compliance & Enforcement Team examines the Food and Drug Administration’s decision to temporarily postpone routine surveillance domestic inspections in the wake of the continuing coronavirus (COVID-19) outbreak....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
Our FDA Compliance & Enforcement Team examines the Food & Drug Administration’s decision to stop overseas inspections in the wake of the continuing coronavirus (COVID-19) outbreak....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
U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn, M.D., announced that FDA is postponing foreign inspections through April 2020 in response to the COVID-19 outbreak. Manufacturers, including contract...more
On 10 March 2020, FDA announced that it is postponing most foreign inspections through April 2020. This action comes as the latest in a series of agency responses to the coronavirus (COVID-19) outbreaks in foreign...more