Newsletter - December 14, 2023
2023 - The Year of ChatGPT: Its Effects on Healthcare and FDA Regulations
This year was unquestionably the Year of ChatGPT. It affected all aspects of life, including healthcare and FDA-regulated products. ChatGPT did for artificial intelligence (AI), what iPhones did for smartphones 15 years ago. Although several AI-based medical products have been used in medicine and...Read More
Proposed LDT Rule is The Biggest Impact Event of 2023 in FDA Regulatory Space
There were many developments at the FDA last year such as the approval of multiple cell and gene therapy products, the first CRISPR product approval, the formal end of the pandemic, the rise of remote inspections, and the retirement of the legendary Janet Woodcock. However, the rise of remote inspections...Read More
2023 - The Year of ChatGPT: Its Effects on Healthcare and FDA Regulations
This year was unquestionably the Year of ChatGPT. It affected all aspects of life, including healthcare and FDA-regulated products. ChatGPT did for artificial intelligence (AI), what iPhones did for smartphones 15 years ago. Although several AI-based medical products have been used in medicine and...Read More
Proposed LDT Rule is The Biggest Impact Event of 2023 in FDA Regulatory Space
There were many developments at the FDA last year such as the approval of multiple cell and gene therapy products, the first CRISPR product approval, the formal end of the pandemic, the rise of remote inspections, and the retirement of the legendary Janet Woodcock. However, the rise of remote inspections...Read More