Biosimilars, Clinical Pharmacology and Pharma Conference

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Biosimilars

Clinical Pharmacology

Pharma Conference

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

Agency IQ

JULY 8, 2024

Title Type Comments Close Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 Draft Guidance July 5 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance July 5 Financial Transparency and Efficiency of the Prescription (..)

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

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

FDA

FDA Science Regulations Clinical Trials

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 May and June 2024

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