Episode 315 - Boeing Pays $51 Million for ITAR Violations
When products in your shipment violate—or appear to violate—FDA laws and regulations, the FDA may detain your product and issue a Notice of FDA Action with the designation of “Detained.” This notice is considered the Notice...more
The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more
On August 11, 2023, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued an untitled letter to Exeltis USA Inc. (Exeltis) regarding a promotional social media sponsored post...more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
The Bioresearch Monitoring Program (BIMO), run by the U.S. Food and Drug Administration (FDA), oversees the conduct of on-site inspections and data audits of FDA-regulated research in support of new product development and...more
On May 4, 2022, the Food and Drug Administration (FDA) issued warning letters to five companies it asserts are illegally marketing products labeled as containing delta-8 tetrahydrocannabinol (Delta-8 THC) in ways that violate...more
For healthcare and life sciences companies, regulatory disputes with the U.S. Department of Health and Human Services (HHS) and its operating divisions can present significant economic costs and reputational risks. Efficient...more
The Situation: Manufacturers of allergenic extracts that are injected into a patient must obtain a Food and Drug Administration ("FDA") approved license in order to ensure their products are safe for consumption. Until the...more
On January 8, 2021, in the first appellate decision of the year addressing a False Claims Act case, the Fourth Circuit affirmed the summary judgment dismissal of relators’ claims that a manufacturer of allergenic extracts...more
U.S. authorities are actively policing entities making illegal promotional claims that products mitigate, prevent, treat, cure, or diagnose COVID-19....more
LEGISLATION, REGULATIONS & STANDARDS - Virginia Law Limiting Use of “Milk” Advances - Following a vote in the Virginia House Agriculture Subcommittee, the state’s House of Delegates will reportedly consider a bill that...more
The cannabidiol (CBD) industry has been on the receiving end of over a half dozen new consumer class actions in recent weeks, which is likely only the beginning for the emerging industry....more
Paul Singer’s Elliott Management hedge fund revealed a $3.2 billion stake in AT&T and, along with it, a healthy-skepticism of the company’s 2018 purchase of Time Warner and general calls to divest as part of a 24-page letter...more
The U.S. Food and Drug Administration (FDA) recently issued the first Warning Letter addressing violations of the Foreign Supplier Verification Program (FSVP) rule, one of the seven major FDA Food Safety Modernization Act...more
On Tuesday, FDA announced the entry of a consent decree of permanent injunction against Keystone Laboratories, Inc. of Memphis, Tennessee for manufacturing OTC hair care and skin care products in violation of Current Good...more
We have previously reported on the ongoing cybersecurity issues with St. Jude defibrillators [view related posts here, here, and here]. On June 29, 2018, the Food and Drug Administration (FDA) classified the required firmware...more
FDA Issues Draft Guidance for Homeopathic Drug Products - The U.S. Food and Drug Administration (FDA) has issued draft guidance, "Drug Products Labeled as Homeopathic," that would prioritize enforcement and regulatory...more
Last week, FDA published a January 3, 2018 Warning Letter issued to American CryoStem for marketing Atcell—an adipose tissue derived stem cell product—without FDA approval and for several drug current Good Manufacturing...more
On November 1, 2017, the Food and Drug Administration (FDA) published a release concerning its issuance of warning letters to four companies concerning the marketing of products containing cannabidiol (CBD)....more
The use of beauty products is “an understudied source of environmental chemical exposures” with a disparate effect on women of color, George Washington University and Occidental College researchers argue. Ami R. Zota, et al.,...more