Build America Buy America What is it? How to qualify.
Podcast - The FTC Takes Action Against Old Southern Brass for False "Made in the USA" Claims
Powering Through the Environmental Challenges of EV Development - Energy Law Insights
Wiley's 10 Key Trade Developments: The CHIPS Act and Inflation Reduction Act (IRA)
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
In July, the Senate Armed Services Committee passed its version of the FY 2025 National Defense Authorization Act (NDAA), which would make substantial changes to the rules for determining the “country of origin” of drugs for...more
The U.S. Food and Drug Administration (FDA) recently released a draft guidance describing its proposed approach to reviewing and authorizing a predetermined change control plan (PCCP) in a marketing submission for a device...more
The U.S. Food and Drug Administration (FDA) has published new draft guidance on “Predetermined Change Control Plans for Medical Devices,” which describes the process by which device sponsors may seek FDA approval for...more
Many life sciences stakeholders are familiar with “traditional” designation programs operated by the Food and Drug Administration (FDA) in exercising its medical product authorities, such as the orphan drug designation and...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 22, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion 24-05, evaluating two manufacturer-sponsored assistance programs under the federal Anti-Kickback...more
Legal challenges for innovative cell, tissue, and gene therapies (CTGTs) are mainly seen in the still evolving regulatory environment. However, it is also crucial for the manufacture and supply of CTGTs to have agreements in...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
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
We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Zurich, where co-head of Hogan Lovells Life Sciences and Health Care sector Jane Summerfield, and partners Melissa K. Bianchi,...more
In the first half of 2024, the U.S. Food and Drug Administration (FDA) has continued to ramp up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened...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
On June 17, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted a favorable Advisory Opinion 24-03 (“AO 24-03”) involving a pharmaceutical manufacturer’s proposed patient...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
The California Supreme Court granted review in Gilead Life Sciences v. Superior Court—a hopeful turn of events after lower courts issued decisions that resulted in an unprecedented expansion of negligence liability for...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 issued draft guidance on its “Platform Technology Designation Program,” which aims to streamline drug development, manufacturing, and marketing application review for products...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 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
On May 21, 2024, the United States Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) issued its decision in United Therapeutics Corporation v. Carole Johnson, et al./Novartis Pharmaceuticals v. Carole...more
On May 21, the U.S. Court of Appeals for the D.C. Circuit issued a unanimous decision in favor of drug manufacturers, finding that certain manufacturer restrictions on the use of contract pharmacies under the 340B drug...more
Are you responsible for privacy compliance at your company? Sharpen your pencils and grab your highlighters for this three-part series on critical privacy laws, DPOs and privacy officers (and when you should appoint one), and...more