Leaders in Law: The State of International Trade with Neena Shenai
The Justice Insiders Podcast - The Ever-Expanding Net: Corporate Compliance in an Era of Increasing Trade Sanctions and Restrictions
A Third Party's Perspective on Third Party Risk
AGG Talks: Cross-Border Business Podcast - Episode 18: Navigating U.S. Sanctions and Their Implications for Non-U.S. Individuals and Entities
Episode 328 -- Sanctions Enforcement Risks and Redlines
4 Key Takeaways | Solar Industry & Chinese Tariff Update
Hidden Traffic Podcast: Trade Law and Human Rights with Dean Pinkert
Compliance into the Weeds: Sustainability and Managing 3rd Party Risk
Hot Topics in International Trade. BLG VP Marketing Bob Brewer sits down with Robert Stein, VP Braumiller Consulting Group and discusses the recent bridge collapse via the Dali at the Francis Scott Key
The ESG Report: EV Battery Regulation and Compliance in The US & EU-Part 1, Foreign Entities of Concern
Perfecting High-Performance Battery Chemistry With John Kem, American Battery Factory — Battery + Storage Podcast
Hot Topics in International Trade-The Mod Act
Episode 309 -- Alex Cotoia on Compliance with the Uyghur Forced Labor Prevention Act
10 Key Trade Developments: China
Hot Topics in International Trade
Video: Making Trade Inclusive for All Americans: A Conversation with AAEI's Eugene Laney Jr., Ph.D.
Hot Topics in International Trade- A Year in Review (Quickly) with Braumiller Law Group Attorney Brandon French
Hot Topics in International Trade A Year in Review (Quickly)
Domesticating the Battery Supply Chain With ENTEK and KORE Power — Battery + Storage Podcast
Across the United States, a broad legal spectrum has developed regarding the use of marijuana, thus creating great uncertainty among employers that have long striven to maintain drug-free workplaces. Federally, marijuana...more
Several states are considering or have enacted legislation to create prescription drug affordability boards (PDABs). Although their powers vary by state, PDABs are generally charged with assessing the affordability of...more
Earlier this month, the American Society of Pharmacy Law hosted its annual conference in San Antonio, TX. This gathering of industry leaders provided a unique opportunity to delve into the ever-evolving landscape of pharmacy...more
Although 340B-participating covered entities likely don’t need the reminder, numerous manufacturers continue to significantly restrict 340B pricing available via traditional “bill to/ship to” contract pharmacy models, with...more
The price of prescription drugs has brought scrutiny to the entire drug supply chain. Congress and other policymakers continue to seek opportunities to lower costs for patients and the federal government. Pharmacy benefit...more
On Friday, August 25th, the Food and Drug Administration (“FDA”) issued a guidance document extending the November 27, 2023 enforcement deadline for drug and device manufacturers, wholesale distributors, dispensers, and...more
On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more
On June 27, 2023 the FDA published Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. In this draft guidance, FDA provides examples of activities prohibited...more
For the last three years, the federal government has taken considerable steps to aid providers in the fight against COVID-19. Although many of the waivers and flexibilities initiated in response to the pandemic have since...more
In one year (plus a few days, as of this writing), regulation of the U.S. drug supply chain will be historically changed. On November 27, 2023, the final phase of the Drug Supply Chain Security Act (DSCSA) goes into effect....more
On February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay...more
Since our last update, the Senate confirmed Dr. Robert Califf as commissioner of the U.S. Food and Drug Administration. The FDA resumed domestic and foreign inspections. The agency also published a proposed rule to update...more
The US Food and Drug Administration (FDA) published its proposed rule National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers on February 4, 2022. The proposed rule sets...more
On February 4, 2022—more than six years after the deadline imposed by statute—the U.S. Food and Drug Administration (“FDA”) issued a proposed rule titled “National Standards for the Licensure of Wholesale Drug Distributors...more
New federal regulations have been proposed that will affect licensure of wholesale drug distributors and third-party logistics providers (3PLs). The Drug Supply Chain Security Act became law in 2013. The U.S. Food and Drug...more
340B PROGRAM - Further State Legislation Seeks to Regulate PBMs in Relation to 340B: Florida, Kentucky, Missouri, Nebraska, and New Hampshire recently introduced legislation aiming to regulate pharmacy benefit managers...more
Earlier in the summer, the FDA issued a quartet of guidance documents setting forth the Agency’s plan for implementing requirements under the Drug Supply Chain Security Act (DSCSA). The DSCSA directs FDA to build an...more
Food - FDA Released Retail Food Employee Health Handbook – The FDA published the Employee Health and Personal Hygiene Handbook to help food employees avoid spreading viruses and bacteria to food....more
On June 8, 2020, the Food and Drug Administration (FDA or Agency) issued temporary guidance to address concerns related to distribution of drug samples during the COVID-19 public health emergency....more
WHAT ARE THEY? Sometimes the needs of a patient are so unique that prescription medications readily available at retail drug stores are not sufficient to combat the illness or treat the condition. An example of such a...more
With COVID-19 cases on the rise in the United States, some hospitals have faced shortages of FDA-approved drug products used to treat the disease. ...more
With this update, we have covered and provided Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and state boards of pharmacy actions related to COVID-19 for more than one month. This update will...more
Multiple regulatory agencies continue to do their part in the fight against COVID-19. This week, the U.S. Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) and state boards of pharmacy all acted to...more
Tens of millions of Americans may have been startled in recent days by the much-publicized pulling from the shelves of widely used drugs like ranitidine (aka Zantac), an over-the-counter heartburn remedy, and select lots of...more
Blockchain technology originated in 1991, and was conceived as a secure way to timestamp digital documents akin to how a notary timestamps physical documents. The true value lies in the fact that once stamped, the document...more