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
In January 2025, the US Food and Drug Administration (FDA) finalized its 2023 revised draft guidance Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more
On January 6, 2025, FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.” This...more
The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry titled, “Communications From Firms to Health Care Providers Regarding Scientific Information...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
Since our last update, the Senate confirmed Dr. Robert Califf as commissioner of the U.S. Food and Drug Administration. The FDA resumed domestic and foreign inspections. The agency also published a proposed rule to update...more
The U.S. Food and Drug Administration (FDA) recently issued final guidance regarding the initiation of voluntary product recalls “to help companies prepare to quickly and effectively remove violative products from the...more
FDA’s recent release of new guidance on civil money penalties for the failure to submit required information to the ClinicalTrials.gov data bank may indicate a renewed interest in the enforcement of these requirements. On...more
Drug and medical device manufacturers seeking to export a product from the United States may need to obtain from the U.S. Food and Drug Administration (FDA) a Certificate to Foreign Government (CFG) in order to satisfy the...more
Federal Court finds invalidity allegations relating to patent for metformin formulations not justified - On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of...more
On 17 December 2018 the U.S. Food and Drug Administration (FDA) issued a final guidance document intended to help manufacturers determine the appropriate premarket approval (PMA) application supplement reporting pathway for...more
A Summary of Final Guidances for Communications That Are Consistent with FDA-Required Labeling and Communications with Payors - On June 12, 2018, the Food and Drug Administration (FDA or Agency) finalized two draft...more
The U.S. Food and Drug Administration (FDA) released two final guidances yesterday regarding medical communications: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities —...more
On September 26, 2017, the Food and Drug Administration (FDA) published a final guidance document providing further clarity on how FDA classifies a product as a drug, device, biological product, or a combination product,...more