Podcast: Unpacking FDA's Final Clinical Decision Support Guidance - Diagnosing Health Care
Wiley Webinar: Biotech Briefings – Interim Update on Regulatory Developments Relevant to Plant Biostimulants
Edible Bites Episode 2: Cannabis and Life Sciences Video Webinar Series
FDA issues final guidance on lead in baby food. FDA has issued its Final Guidance on Action Levels for Lead in Processed Food Intended for Babies and Young Children as part of its Closer to Zero initiative to reduce dietary...more
On February 14, 2024, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the National Institute of Standards and Technology (NIST) published a new, final version of their guidance for...more
On September 27, 2023, FDA finalized its guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (the “2023 Final Guidance”). The Final Guidance replaces...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
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
The Department of Defense (DOD) and its component services and agencies are taking several independent steps to assess and enhance their cyber and supply chain security that will directly or indirectly affect DOD contractors...more
On September 6, 2017, the Food and Drug Administration (FDA or the Agency) released its final guidance document, Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices (Final...more
In October of 2011, the U.S. Securities and Exchange Commission (“SEC”) issued guidance regarding a public company’s obligations to disclose cybersecurity risks and cyber incidents (the “Cybersecurity Disclosure Guidance”)....more
Last month, the Equal Employment Opportunity Commission (EEOC) issued a final enforcement guidance on retaliation claims under the various federal civil rights laws administered by the agency. The guidance will replace...more
In past posts we’ve taken a close look at the Framework for Improving Critical Infrastructure Cybersecurity put forth by the National Institute of Standards and Technology (NIST), exploring its wide-ranging implications for...more