[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
As the manufacturing sector continues to embrace the hyper-connected era of Smart Manufacturing, known as Industry 4.0, more and more organizations are integrating advanced automation, artificial intelligence (AI), the...more
The Department of Health & Human Services’ Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical companies to develop and implement...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
The Arkansas Department of Environmental Quality (“ADEQ”) and Armtec Countermeasures Co. (“ACC”) entered into a March 29th Consent Administrative Order (“CAO”) to address alleged violations of Arkansas Pollution Control &...more
This is the first episode in K&L Gates’ three-part series on the 340B Program with Chris Hatwig, President of Apexus, LLC. Apexus serves as HRSA’s Prime Vendor in administering the 340B Program, including by publishing...more
Over the past several months, the Health Resources and Services Administration (HRSA) has issued a number of guidance updates related to the agency's expectations for health care providers participating in the 340B drug...more
The North Carolina Court of Appeals recently issued a ruling that will have a significant impact on business transactions involving property subject to a permit or corrective action obligations under the Resource Conservation...more
The United States Consumer Product Safety Commission (CPSC) recently announced a $5.8 million agreement with Keurig Green Mountain, Inc. settling claims that Keurig failed to report a product defect that posed an unreasonable...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
Welcome to the April edition of the Alston & Bird CPSC Recall Snapshot. Last month, Administrative Law Judge Dean C. Metry issued a ruling against the CPSC in litigation with Zen Magnets over its small-diameter magnetic...more
On July 22, 2015, the U.S. Consumer Product Safety Commission and major furniture company IKEA jointly announced a “repair program” to address the serious and complex hazard of furniture tip-over posed by 27 million chests...more