On Friday, August 25th, the Food and Drug Administration (“FDA”) issued a guidance document extending the November 27, 2023 enforcement deadline for drug and device manufacturers, wholesale distributors, dispensers, and...more
Food/Dietary Supplements - FDA Investigation Into Salmonella Outbreak – The Food and Drug Administration (FDA) announced that it is investigating a multistate outbreak of Salmonella enteritidis it believes is linked to shell...more
On October 17th, the Administration released its semiannual forecast of the rules that the Department of Health and Human Services (HHS) will be churning out over the next year. The list includes nearly 200 rules, 23 of which...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
I. REGULATIONS, NOTICES, & GUIDANCE - On April 15, 2016, the Food and Drug Administration (FDA) issued a proposed rule entitled, “Applications for Approval and Combinations of Active Ingredients Under Consideration for...more
This Week: 21st Century Cures Legislation Passes House in Bipartisan Vote... CMS Releases Proposed CY 2016 Home Health Prospective Pay Rule... CMS Releases Final CY 2016 Hospital Outpatient Prospective Payment System (OPPS)...more