Packaging, Pharma Conference and Therapies

Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

Agency IQ

AUGUST 2, 2024

September 30, 2024 PDUFA Novel Approaches to Development of Cell and Gene Therapy Convene a public meeting to solicit input on methods and approaches (e.g., use of RWE, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products.

FDA

FDA Science Regulations Biosimilars

Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Agency IQ

JULY 8, 2024

Letter Program Tag Commitment Due Date PDUFA Advancing RWE Program Report containing aggregated and anonymized information describing RWE submissions to CDER and CBER.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Agency IQ

MAY 3, 2024

Trial Designs for Treatment Regimens with Multiple Phases Workshop Office of the Commissioner 05/09/2024 05/09/2024 Blood Products Advisory Committee May 9, 2024 Meeting Announcement Advisory Committee Meeting CBER 05/09/2024 05/09/2024 Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval Virtual CDER 05/09/2024 (..)

FDA

FDA Science Regulations Clinical Trials

Drug Discovery Digest

Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

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