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FDA increasing efforts to support CTGT product development | Hogan Lovells

FDA has recently increased its efforts to support the development and approval of cell, tissue, and gene therapy (CTGT) products. This is evidenced by the upswing in CTGT approvals in...

FDA Helps to Deliver Meaningful Advances for Rare Disease Patients

We remain committed to supporting rare disease research, engaging patients and caregivers to understand their unique perspectives, and enhancing our review processes to advance medical products for rare disease patients.

JPM2024: What to expect from FDA in an election year | Hogan Lovells

Despite continued perceived economic headwinds, cutting edge research continues to provide new opportunities for life saving therapies for patients. However, early development programs...

Breaking barriers: strategies for expanding patient access to cell and gene therapies

Which Therapeutic Areas Experts Think Will Gain Traction In 2024

Dr. Gregory Scott Brown's brand Rx for reducing holiday stress

Board-certified psychiatrist Dr. Gregory Scott Brown says health brands should pick up on peoples’ need for self-care during the holidays. Lecia Bushak discusses an FDA pilot program aiming to boost rare disease therapeutics development. And Snapchat’s Botox activation on AR Lens tops our Trends segment.

Recent FDA Initiatives to Support Development of Individualized Cell and Gene Therapies and Rare Disease Therapies | Goodwin

​​​​​​​Last month, FDA issued a Request for Information (RFI) in the Federal Register seeking information and comments from interested stakeholders regarding “critical scientific...

Meeting on the Mesa: How to Bring Cell and Gene Therapies to Market

New FDA Pilot Program Will Provide Hands-On Regulatory Guidance for Cell and Gene Therapy Trials in Rare Disease

The program will initially allow 6 sponsors of clinical trials to participate and will provide sponsors with the opportunity for frequent advice and regular communication regarding clinical trial design and other development issues.

FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies