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2 months ago | 
ladailypost.com | Esteban Candelaria |Nathan Brown |Carol Clark
Sen. Joseph CervantesBy ESTEBAN CANDELARIA and NATHAN BROWNThe Santa Fe New MexicanBills to crack down on crime and improve New Mexico’s behavioral health system took major steps forward Friday and may reach the governor’s desk soon. House Bill 8, which would reform criminal competency laws as well as cracking down on shooting threats, fentanyl trafficking and drunken driving, passed the Senate 38-3 Friday evening after extensive debate.
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Jan 14, 2025 | 
jdsupra.com | Anna K. Abram |Nathan Brown
January 14, 2025
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On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance of body weight in patients with obesity or who are overweight.
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Jan 14, 2025 | 
akingump.com | Anna K. Abram |Nathan Brown
By: Anna K. Abram, Nathan A. BrownOn January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance of body weight in patients with obesity or who are overweight.
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Dec 16, 2024 | 
jdsupra.com | Nathan Brown
On December 12, 2024, FDA’s Center for Drug Evaluation and Research (CDER) announced a new CDER Center for Real-World Evidence Innovation (CCRI). The CCRI is intended to serve as the focal point to promote more efficient and consistent communications across CDER offices regarding real-world data (RWD) and real-world evidence (RWE). Advancing the use of RWD/E has been a priority for the agency and for manufacturers.
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Dec 10, 2024 | 
mondaq.com | Cheese Consumers |Anna K. Abram |Nathan Brown |Caroline D. Kessler
On December 5, 2024, FDA unveiled the draft guidance for industry regarding
accelerated approval for drugs and biologics. This guidance
provides additional information regarding the development of drugs
and biologics to treat serious conditions for which there is an
unmet need, and for which the sponsor is seeking accelerated
approval.
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Dec 6, 2024 | 
akingump.com | Anna K. Abram |Nathan Brown |Caroline D. Kessler
By: Anna K. Abram, Nathan A. Brown, Caroline D. KesslerOn December 5, 2024, FDA unveiled the draft guidance for industry regarding accelerated approval for drugs and biologics. This guidance provides additional information regarding the development of drugs and biologics to treat serious conditions for which there is an unmet need, and for which the sponsor is seeking accelerated approval.
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Dec 5, 2024 | 
jdsupra.com | Nathan Brown |Marlee Gallant
December 5, 2024
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Today FDA issued final guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI) enabled device software functions.
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Dec 4, 2024 | 
jdsupra.com | Nathan Brown
In this edition of Three Questions, health care & life sciences partner Nate Brown spoke with Jeremy Schutz, director of business development, recall & remediation at Sedgwick, to explore key strategies that pharmaceutical companies and medical device manufacturers can adopt to mitigate risks related to supply chain disruptions, cybersecurity threats and increased FDA enforcement of quality control and compliance.
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Dec 4, 2024 | 
akingump.com | Nathan Brown |Marlee Gallant
By: Nathan A. Brown, Marlee P. GallantToday FDA issued final guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI) enabled device software functions. FDA recognizes that development of AI-enabled devices is an iterative process, and PCCPs are intended to allow developers to plan for modifications, while continuing to provide a reasonable assurance of safety and effectiveness.
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Dec 4, 2024 | 
akingump.com | Nathan Brown
Reading Time : 2 minIn this edition of Three Questions, health care & life sciences partner Nate Brown spoke with Jeremy Schutz, director of business development, recall & remediation at Sedgwick, to explore key strategies that pharmaceutical companies and medical device manufacturers can adopt to mitigate risks related to supply chain disruptions, cybersecurity threats and increased FDA enforcement of quality control and compliance.
