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FDA Furthers Efforts to Improve the Accelerated Approval Pathway through New Draft Guidance on Confirmatory Trials
On January 6, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway” (the “Draft Guidance”). The Draft Guidance responds to FDA’s new authorities and responsibilities in administering the accelerated approval program under the 2023 Consolidated Appropriations Act,…
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The U.S. Patent and Trademark Office (USPTO) Fee Changes – What You Need to Know
The USPTO has announced fee increases and new fees for patents and trademarks to take place on January 18, 2025, for trademarks, and January 19, 2025, for patents. The increase in fees and the introduction of new fees by the USPTO is significant, necessitating careful budget considerations requiring many applicants to adjust filing and prosecution…
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The EU Cyber Resilience Act – What You Need to Know
The EU Cyber Resilience Act (CRA) entered into force on 10 December 2024. The CRA is the first legislation of its kind in the world that aims to enhance the cyber security of products or software with a digital component that are omnipresent in our daily lives (ranging from baby monitors, smart watches, and computer…
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Major Changes in PTO Fees Effective January 19, 2025
The United States Patent and Trademark Office (USPTO) has issued a final rule setting out patent fee increases that will come into effect on January 19, 2025. The USPTO states that costs justify an increase of 10% for up-front fees and 7.5% for other fees except where special circumstances apply and larger increases are justified.…
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Certain DSCSA Deadline Extensions Set to Eclipse in 2025
The Drug Supply Chain Security Act (DSCSA) (section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 USC §360eee – 1) was introduced in response to several drug contamination, counterfeiting, and diversion incidents, including the 2008 case of adulterated heparin….By: DLA Piper
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EncompassCare Files Notice of Data Breach Affecting Consumers’ Social Security Numbers
On January 9, 2025, EncompassCare filed a notice of data breach with the Attorney General of Massachusetts after discovering that an unauthorized party was able to access confidential information that had been entrusted to the company. In this notice, Encompass Care explains that the incident resulted in an unauthorized party being able to access consumers’…
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FDA Publishes Guidance on Medical Device Shortages During Public Health Emergencies
Our FDA/Food, Drug & Device and Health Care teams discuss new guidance from the Food and Drug Administration (FDA) on federal notification requirements for medical device manufacturing shortages during public health emergencies (PHEs)….By: Alston & Bird
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Pittsburgh Jury’s Attempt to Award $22 Million in Johnson & Johnson Talc Case Highlights Trial Complexities
On Jan. 6, a Pittsburgh jury concluded a month-and-a-half long trial involving a suit asserting that decedent Michaeleen Lee developed mesothelioma from exposure to asbestos-containing talcum powder products made by Johnson & Johnson. The jury found that Johnson & Johnson was negligent in misrepresenting the safety of its talcum powder products….By: Goldberg Segalla
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Israel and Hamas Near Agreement on Cease-Fire Deal, Qatar Says
The negotiations, mediated by Qatar, Egypt and the United States, appear to be making progress after months of failed attempts to achieve a breakthrough.
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How Mexico Cracked Down on Its Immigration Chief to Defuse a US Migrant Crisis
When border crossings grew out of control in 2023, the U.S. pressured Mexico to do something. Officials rebuked the immigration chief and stripped him of a key power, an investigation shows.
