Build America Buy America What is it? How to qualify.
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Perfecting High-Performance Battery Chemistry With John Kem, American Battery Factory — Battery + Storage Podcast
Hot Topics in international trade
Video: Making Trade Inclusive for All Americans: A Conversation with AAEI's Eugene Laney Jr., Ph.D.
(Podcast) The Briefing: Are LEGO Creations Based on Religious Texts Eligible for Copyright Protection?
The Briefing: Are LEGO Creations Based on Religious Texts Eligible for Copyright Protection?
Hot Topics in International Trade A Year in Review (Quickly)
Domesticating the Battery Supply Chain With ENTEK and KORE Power — Battery + Storage Podcast
What to Do if Your Suppliers Are in Distress - Is It Time to Find a New Supplier?
What to Do if Your Suppliers Are in Distress - Candid Conversations with Suppliers in Distress
What to Do if Your Suppliers Are in Distress - Identifying Suppliers in Distress
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
Podcast - Made in the USA Claims
The Labor Law Insider: Union Activity, Employment Engagement, and Changes in the Manufacturing Industry
WorldSmart: The Move to Mexico— Why Companies are Setting Sights on Mexico Post COVID
Proposition 65 – Changes That Will Impact the Cannabis Sector
Five Questions, Five Answers: Driving the I-75 with Rick Walker of GAMA Georgia
The U.S. Food and Drug Administration (FDA) recently released a draft guidance describing its proposed approach to reviewing and authorizing a predetermined change control plan (PCCP) in a marketing submission for a device...more
The U.S. Food and Drug Administration (FDA) has published new draft guidance on “Predetermined Change Control Plans for Medical Devices,” which describes the process by which device sponsors may seek FDA approval for...more
The U.S. Food and Drug Administration (FDA) has issued a Safety Communication advising healthcare providers to stop implanting Equinoxe Shoulder System joint replacement devices manufactured by Exactech. The Safety...more
The U.S. Food and Drug Administration (FDA) recently released draft guidance on how and when medical device manufacturers and pharmaceutical companies can respond to misinformation about their products online. While not yet...more
The U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs,” which clarifies how firms can address misinformation about their...more
The Food and Drug Omnibus Reform Act of 2022 (“FDORA” or the “Act”), signed into law on December 29, 2022, required, in part, drug and device manufacturers to submit Diversity Action Plans to the U.S. Food and Drug...more
The U.S. Food and Drug Administration (FDA) is reaffirming its plans to actively regulate certain laboratory developed tests (LDTs) that the FDA has historically treated with enforcement discretion. On June 25, 2024, the FDA...more
Exactech has issued multiple recalls for its implantable joint replacement devices over the past few years. While Exactech has largely issued these recalls voluntarily, it has done so at the request—and with the oversight—of...more
The U.S. Food and Drug Administration (FDA) announced yesterday a “Small Entity Compliance Guide” (SECG) for Laboratory Developed Tests (LDTs), aiming to assist small entities in complying with FDA’s LDT final rule, which...more
In response to scrutiny from the U.S. Food and Drug Administration (FDA), Exactech has recalled hundreds of thousands of defective medical implant devices sold between 2004 and 2021. Despite these recalls—which began in...more
After many years of anticipation and various congressional and agency proposals, on May 6, the Food and Drug Administration (FDA) published its final rule titled "Medical Devices; Laboratory Developed Tests." The final rule...more
The 1980s British rock band, The Fixx, comes to mind when one reads the Food and Drug Administration’s recently issued “Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug...more
The U.S. Food and Drug Administration (FDA) has finalized its guidance on “Remanufacturing of Medical Devices,” clarifying the point when manipulation or repair of a medical device becomes “remanufacturing” as opposed to...more
While the US Food and Drug Administration’s recently issued Final Guidance on Remanufacturing of Medical Devices provides clarity and attempts to reign in certain activities, the agency continues to defer enforcement for...more
At the end of 2022, FDA published a draft guidance on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. The draft guidance explains several aspects of the VMSR Program, including FDA’s approach to...more
One of the catchiest songs written by the 1970s British glam rock band, Sweet, is “Love Is Like Oxygen,” released in 1978. The chorus includes the lyrics, “Love is like oxygen; you get too much, you get too high.” Apparently,...more
The U.S. Food and Drug Administration ("FDA") has proposed updated guidance, intended to assist individuals in meeting the cybersecurity requirements for FDA medical device submissions....more
n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more
Manufacturers of all types of products have been using per- and polyfluoroalkyl substances (PFAS) for decades. From a manufacturing perspective, PFAS have several benefits, including resistance to grease, oil, water, heat and...more
There are many junctures in the U.S. healthcare system that enable fraudulent activities, and one of the biggest has to do with pharmaceutical companies. The U.S. Food and Drug Administration (FDA) and the Department of...more
Over the past couple of decades, hundreds of thousands of patients in the United States have received defective medical implants manufactured by Exactech. While the U.S. Food and Drug Administration (FDA) has identified...more
Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with...more
As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more
On February 2, 2024, the US Food and Drug Administration (FDA) published a much-awaited final rule: the Quality Management System Regulation (QMSR). By issuing this rule, FDA amended the medical device current good...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