Licensing, Packaging, Pharma Conference and Therapies

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

Agency IQ

JULY 8, 2024

The following PDUFA dates were obtained from publicly available sources. 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 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

Drug Discovery Digest

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 August and September 2024

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

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