Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....more
On July 8th, the Food and Drug Administration (FDA) submitted a report to the House and Senate Committees on Appropriations detailing the results of a sampling study of the current cannabidiol (CBD) marketplace....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 and highlights articles from members of AGG outside the Food and Drug practice....more
Importing dietary supplements and dietary supplement components can present many challenges. Not the least of which are those required to stay in compliance with aspects of the Food Safety and Modernization Act (FSMA)....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 and highlights articles from members of AGG outside the Food and Drug practice....more
On May 15, 2020, the Food and Drug Administration (FDA or “Agency”) announced a voluntary recall of a CBD containing product that tested positive for lead.1 According to information shared by FDA, the recalling firm is...more
The novel Coronavirus and the response by federal and state government agencies has been unprecedented in its nature and scope. This is certainly true for the manufacture and sale of dietary supplement products. ...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 and highlights articles from members of AGG outside the Food and Drug practice....more
On March 31, 2020, the Food and Drug Administration issued a Warning Letter to a dietary supplement firm for making claims about its products that establish the products are unapproved new drugs, in violation of Federal Food,...more
As we continue to learn more about the Coronavirus Aid, Relief and Economic Security Act (CARES Act), we are committed to sharing our knowledge and understanding of the bill with our clients.
In this webinar, we provided a...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 and highlights articles from members of AGG outside the Food and Drug Practice....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 and highlights articles from members of AGG outside the Food and Drug Practice....more
On January 13th, 2020, Representative Collin Peterson (D-MN), with co-sponsors Rep. Thomas Massie (R-KY), Rep. James Comer (R-KY), and Rep. Chellie Pingree (D-ME), filed a bill that offers a reasonably pragmatic solution to...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
Introduction -
When many long-term care providers first hear about USP General Chapter <800> Hazardous Drugs–Handling in Healthcare Settings (“USP 800”), they naturally confuse it with the final EPA hazardous...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
When clients seek out legal assistance about regulatory issues concerning one of their products, frequently, the first task is to determine exactly what the product “is.” Most would assume that this determination is made by...more
When many long-term care providers first hear about USP General Chapter <800> Hazardous Drugs--Handling in Healthcare Settings (“USP 800”), they naturally confuse it with the final EPA hazardous pharmaceuticals rule (“EPA...more