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How to Negotiate Cell & Gene Therapy Contracts with German Treatment Centers – Trends in Cell, Tissue, and Gene Therapies
For autologous cell and gene therapies (CGTs), the collection of patients‘ cells is the first step in the manufacture of the medicinal product. In Germany, this step is usually conducted by specialized treatment centers that have their own cell collection unit and thus handle both the cell collection as well as the later storage, handling,…
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From Vulnerability to Violation: FDA Cybersecurity Requirements for Medical Devices and FCA Enforcement
In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (2025 Cybersecurity Guidance). This guidance updates the 2023 guidance of the same title with the agency’s interpretation of and compliance recommendations for new requirements for “cyber devices” under…
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Holland & Knight Health Dose: November 4, 2025
This week, the government shutdown entered its fifth week and, on Nov. 4, 2025, became the longest in history, beating a 34-day-plus record set during President Donald Trump’s first term. Meanwhile, the Open Enrollment Period (OEP) began on Nov. 1, 2025, allowing consumers to view, choose and enroll in coverage through the Affordable Care Act…
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5 Key Takeaways | Federal Court Standing in Cases Alleging Consumer Products that Contain Harmful Chemicals (like PFAS or BPA) or Fail to Contain the Advertised Level of Key Compounds
Kilpatrick’s Evan Nadel recently presented at the 2025 ANA Masters of Advertising Law Conference on the topic of “Federal Court Standing in Cases Alleging Consumer Products That Contain Harmful Chemicals (like PFAS or BPA) or Fail to Contain the Advertised Level of Key Compounds.”…By: Kilpatrick
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Elizabeth Tsurkov Recounts 2 1/2 Years of Captivity
Elizabeth Tsurkov, a citizen of Israel and Russia, recounts a harrowing story of cruelty, survival, U.S. diplomatic pressure and, finally, release from the grip of a group backed by Iran.
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Scars in the Blue Mosque Reveal Afghanistan’s Rifts
The namesake of Mazar-i-Sharif suffered countless cracks in a 6.3-magnitude quake, but, like Afghanistan, it has endured for centuries.
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In Russia, Bookstores Offer a Shrinking Refuge as Censorship Tightens
Restrictions on publishers and sellers have grown more severe. Volumes are being pulled from shelves or redacted like secret documents, but bookstores remain important sources of community.
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How Venezuela’s Military Might Respond to U.S. Attacks
Venezuela has an arsenal of Russian weapons and armed civilian cells that could mount a guerrilla war. But a coup against President Nicolás Maduro? Don’t count on it.
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Zohran Mamdani’s Triumph in the NYC Mayoral Race Evokes Intense Reaction in Israel
“The Big Apple has fallen,” a right-wing lawmaker said, reflecting broader worries in the Mideast country. Palestinians hailed the election as a sea change in the United States.
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Female Filmmakers in Focus: Sepideh Farsi on “Put Your Soul on Your Hand and Walk”
On 16 April 2025, a day after Iranian filmmaker Sepideh Farsi’s intimate documentary “Put Your Soul on Your Hand and Walk” was announced as a selection of the 2025 Cannes Film Festival in the ACID parallel section, the film’s subject, Palestinian photojournalist Fatma Hassona, along with nine members of her family, was killed in an…
