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Wiley's 2025 Key Trade Developments Series: Trade Remedies
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AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
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The Briefing: Are LEGO Creations Based on Religious Texts Eligible for Copyright Protection?
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In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA....more
In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA. Hear from Joanne Hawana and Ben Zegarelli, FDA specialists...more
The Department of Health and Human Services (“HHS”) recently proposed a policy that would require all new vaccines to undergo placebo-controlled clinical trials prior to FDA approval. The proposal, while controversial, is...more
Foley Hoag LLP publishes this quarterly Update primarily concerning developments in product liability and related law from federal and state courts applicable to Massachusetts, but also featuring selected developments for New...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
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
The road to commercializing a life sciences product is a long one, spanning years to perform research, develop the product, conduct clinical trials and testing, and receive approval from the Food and Drug Administration...more
On August 15, 2023, the Food and Drug Administration (FDA) issued its updated guidance on informed consent for clinical investigations. The FDA’s updated guidance is titled Informed Consent Guidance for IRBs, Clinical...more
Biologics have long been defined by their processes, raising complicated questions about how to assess the effect of manufacturing changes on product quality—i.e., whether pre- and post-change products are comparable. This...more
Neuralink, the biotechnology company founded by Elon Musk, has received approval from the U.S. Food and Drug Administration (FDA) to commence human trials of its implantable brain-computer interface device. Recruitment for...more
The U.S. Food and Drug Administration (FDA) has just published a highly-anticipated draft guidance on the implementation of decentralized clinical trials (DCTs) for drugs, biologics, and medical devices. In the draft...more
As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more
On July 23, the U.S. Food and Drug Administration (FDA) announced a new proposed rule that would require sponsors and manufacturers who provide an ‘‘eligible investigational drug’’ under the Right to Try Act to submit an...more
On June 30, 2020, the U.S. Food and Drug Administration (FDA) released new guidance to provide recommendations for sponsors to facilitate development of SARS-CoV-2 vaccines to prevent COVID-19. The guidance highlights key...more
For over 15 years, ACI’s FDA Boot Camp has been the Training Grounds for Life Sciences Attorneys and Executives to Master the Fundamentals of FDA Regulation. Now the conference returns for its 37th iteration, in a fully...more
Life sciences and medical device companies are dealing with an unprecedented crisis. The industry is not only managing the impact of Coronavirus (COVID-19), they are also a solution provider. Companies are rapidly adapting...more
How Federal Preemption (or Lack Thereof) Could Influence the Use of Federal "Right to Try" - As discussed in our Alert of June 4, "Right to Try" Comes to the Federal Stage: What Stakeholders Should Do Now, manufacturers,...more
On May 30, 2018, surrounded by patients directly impacted by tragic and intractable diseases, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017...more
Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more
The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more