FDA | NIH: Regulatory Do’s and Don’ts: Tips from FDA

FDA | NIH: Regulatory Do’s and Don’ts: Tips from FDA - CBER Segment

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This inaugural webinar was a collaborative effort between FDA and NIH’s Small Business Innovation Research (SBIR) Development Center within the National Cancer Institute (NCI). Its purpose was to educate early-stage companies (small businesses) new to the regulatory landscape at the FDA. The genesis of this webinar can be attributed to the work that FDA, specifically SBIA, has contributed to NIH | SBIR in the past few years, and more recently with its Connecting Awardees with Regulatory Experts (CARE) Program.
Timestamps
01:42 - Overview of CBER’s Manufacturers Assistance and Technical Training Branch (MATT)
06:40 - Regulatory Resources and Avenues for Obtaining Early Guidance from CBER/OTP
17:24 - CBER’s CMC Considerations for Early Phase Studies of Cell and Gene Therapy Products
27:35 - Nonclinical Assessment of Cell and Gene Therapy Products to Support an IND
36:35 - Clinical Consideration for Cell and Gene Therapy in Early Phase Study
47:40 - Session II Q&A Panel
Speakers:
Loni Warren Henderson
Public Affairs Specialist
Manufacturers Assistance and Technical Training Branch
Division of Manufacturers Assistance and Training
Office of Communication Outreach and Development | CBER
Heather Erdman, MCPM, RAC, CQPA
Associate Director of Quality Assurance
Office of Review Management and Regulatory Review (ORMRR)
Office of Therapeutic Products (OTP) | CBER
Karin Knudson, PhD
CMC Reviewer
Office of Cellular Therapy and Human Tissue CMC (OCTHT)
OTP | CBER
Devaveena Dey, PhD
Pharmacology-Toxicology Reviewer
Office of Pharmacology-Toxicology (OPT) | OTP | CBER
Jessica Lee, MD, PhD
Branch Chief for the Oncology Branch 2 (OB2)
Division of Clinical Evaluation Oncology (DCEO)
Office of Clinical Evaluation (OCE) | CBER
Peter F. Bross, MD
Chief, Oncology Branch
OTP | CBER
Learn more at: www.fda.gov/dr...
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