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
What to Do if Your Suppliers Are in Distress - Is It Time to Find a New Supplier?
The recent Supreme Court decisions of SEC v. Jarkesy and Loper Bright Enterprises v. Raimondo have the potential to meaningfully impact the implementation and enforcement of the Drug Supply Chain Security Act (“DSCSA”) as...more
In June 2024, the U.S. Food and Drug Administration ("FDA") clarified, with respect to the Drug Supply Chain Security Act (“DSCSA”), that it will not extend the one-year stabilization period for the enhanced drug distribution...more
In January 2024, the Office of Compliance at the FDA’s Center for Drug Evaluation Research (CDER) released its Annual Report for FY2023. The Annual Report contains several useful pieces of information for drug companies and...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
With a November 2023 compliance deadline fast approaching, FDA publishes guidance explaining a one-year delayed enforcement of certain obligations, including interoperable, electronic, and package-level product tracing...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 U.S. Food and Drug Administration (FDA) recently published a guidance for immediate implementation, Enhanced Drug Distribution Security Requirements Under Section 582(g)(1), that provides a one-year reprieve from certain...more
The DSCSA, enacted in 2013, requires entities in the pharmaceutical supply chain to implement security measures to prevent the introduction of counterfeit and illegitimate drugs into the market. One of these measures is the...more
The Food and Drug Administration (“FDA”) released additional guidance documents on Wednesday, August 30th pertaining to the enhanced drug distribution security requirements under the Drug Supply Chain Security Act (“DSCSA”). ...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
Ten years in the making, and full implementation is finally coming. In about a year—beginning on November 27, 2023—prescription drug manufacturers and their supply chain partners will be required to fully trace and verify...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
The US Food and Drug Administration (FDA) has issued a proposed rule—“National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers” (Proposed Rule)—pursuant to FDA’s obligations...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
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
The U.S. Food and Drug Administration (FDA) recently announced the proposed rule, “National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers,” which aims to improve the security...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
On June 3, the U.S. Food and Drug Administration (FDA) issued a series of four documents (two final guidance documents and two draft documents) to provide trading partners guidance on its interpretation of certain...more
As of last week, the Biden Administration announced the 100-day supply chain assessment findings and its global vaccine assistance plan. In addition, the FDA issued a series of guidance documents for the Drug Supply Chain...more
The Drug Supply Chain Security Act was intended to enhance the safety and security of the pharmaceutical distribution supply chain – but in a few short months, everything has changed. Our Food, Drug & Device/FDA Group...more
FDA on September 23 issued a Drug Supply Chain Security Act (DSCSA)– related compliance policy stating it will not take enforcement action against wholesalers that do not have systems in place to verify product identifiers 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
On Feb. 7, 2019, the U.S. Food and Drug Administration (FDA) published a press release and on the following day published an accompanying notice in the Federal Register announcing a Pilot Project Program Under the Drug Supply...more
So far this Fall, the Food and Drug Administration (FDA) has issued four guidance documents regarding the product identifier and verification systems requirements of the Drug Supply Chain Security Act (DSCSA). ...more