[Webinar] EHS in the Cannabis Industry: What Happens When the E stands for Enforcement?
Pamela Para on Effective Investigations in Healthcare
Susan Roberts on Creating a Compliance Program Book
Reasonable minds can differ
Compliance Perspectives: Risk and the 2020 Compliance & Ethics Institute
How to Assess the Likelihood of Success in Deciding Whether to Bring a Bid Protest
The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more
On June 14, 2023, FDA finalized its “Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff” (the “2023 Final Guidance”). The Final Guidance replaces the...more
FDA Warning letters can be harbinger of formal civil and criminal investigations. If your business receives such a notice of non-compliance from the FDA, you should immediately contact an experienced FDA defense attorney....more
Earlier this year, a pet food company issued a recall of its products after reports of animals becoming sick, allegedly, from consuming the company’s pet food. Recalls and their role in ensuring food safety was addressed in a...more
Alere, Inc. and its San Diego subsidiary, agreed to pay $38.75 million to resolve False Claims Act charges for billing the Medicare program for defective rapid point-of-care testing devices. ...more
Effective March 22, 2021, USDA’s Final Rule Sets Forth Regime for Producing Hemp Products in the United States, Superseding Interim Rule - On January 9, 2021, the U.S. Department of Agriculture (USDA) issued a final rule...more
Time Is Ripe To Update SOPs And To Ensure Compliance with Results Submission Requirements - In recent days, the federal Department of Health and Human Services (“HHS”) clarified the requirements for submission of certain...more
West Palm Beach, Florida - The US Food and Drug Administration (FDA), has recently taken the extraordinary step of requiring The Breast Institute at the JFK Medical Center North, located at 2201 45th Street in West Palm...more
Report on Supply Chain Compliance 3, no. 5 (March 5, 2020) - The United States Food and Drug Administration warned Jimmy John’s Franchise LLC that the corporation has “engaged in a pattern of receiving and offering for sale...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Releases Guidance on Intentional Adulteration - The U.S. Food and Drug Administration (FDA) has released the third and final installment of its draft guidance on intentional...more
The U.S. Food and Drug Administration (FDA) has released the third and final installment of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (“IA rule”)....more
On July 22, 2019, the U.S. Food and Drug Administration (FDA) suspended the food facility registration of Topway Enterprises Inc.'s (Topway) Houston, Texas seafood processing facility. As a result, Topway cannot sell or...more
Belladonna is blamed for the deaths of 10 babies. The parents treated their teething phase with homeopathic teething products (gels and tablets) containing the natural substance. Another name for belladona is deadly...more
The Department of Health and Human Services’ Office of Inspector General has recently recommended that the Food and Drug Administration continue to increase its pre-approval inspections of generic drug companies. The OIG...more