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
This year, a laboratory issued a report wherein it claims to have tested over-the-counter and prescription acne products containing benzoyl peroxide and found what it deemed to be “unacceptably high” levels of benzene. In...more
In recent years, China has introduced significant changes to its Drug Administration Law and corresponding legislation, including the nationwide Market Authorization Holder (MAH) system. These reforms aim to boost foreign...more
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more
The Affordable Prescriptions for Patients Act (APPA) of 2023 unanimously passed the Senate on July 11, 2024. The APPA was first introduced to the House on January 30, 2023 by Representative John Cornyn (R-Tx), with the aim of...more
As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more
On July 24, two hospitals that participate in the Section 340B drug discount program—Oregon Health & Science University and Maine General Medical Center—filed separate lawsuits against the Health Resources and Services...more
This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
It has been a busy year for issues related to drug pricing, and with the election around the corner, litigation issues that have been developing over the last few years are likely to be a key focus for the second half of...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 Q2/24 Life Science and Health Care Law Update covers key trends in the EU and Big Five (France, Germany, Italy, Spain, UK) in life sciences regulatory, corporate, compliance, competition, and privacy....more
The Centers for Medicare & Medicaid Services (CMS) recently issued several important updates concerning the reporting of Average Sales Price (ASP) with potential implications for manufacturers. ...more
A group of 21 Democratic AGs filed an amicus brief with the U.S. Court of Appeals for the Ninth Circuit supporting Oregon in its defense of H.B. 4005, which requires pharmaceutical manufacturers to report certain information...more
In Himes v. Somatics, LLC, No. S273887, 2024 WL 3059637 (Cal. June 20, 2024), the Supreme Court of California delivered a win to the defense, upholding the learned intermediary doctrine in cases involving prescription drugs...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
On July 9, 2024, the Food and Drug Administrations (FDA) replaced a 10-year-old draft industry guidance on misinformation and social media information on prescription drugs and medical devices. The new guidance assists...more
On June 20, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 24-04, a favorable opinion analyzing a refund and discount program designed to alleviate the...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 Health Insurance Portability and Accountability Act of 1996 as amended and implemented through regulations at 45 C.F.R. §§ 160 and 164 (“HIPAA”) regulates the privacy and security of health information. For drug and...more
During its meeting on May 20, Maryland’s Prescription Drug Affordability Board (PDAB) unanimously voted to conduct cost reviews on six of eight products it was considering (see table below). Maryland is the third PDAB,...more
On May 21, the U.S. Court of Appeals for the District of Columbia Circuit upheld the right of pharmaceutical manufacturers to place at least some restrictions on the shipment of 340B drugs to contract pharmacies of 340B...more
The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more
At a time when pharmaceutical drug prices are at the height of political scrutiny, manufacturers can breathe a small sigh of relief as the Centers for Medicare and Medicaid Services (CMS) announced on May 15, 2024 that it...more