Fierce BioTech

OCTOBER 26, 2023

Are Gaps in Your Clinical Pharmacology Program Jeopardizing Your Drug’s Approval? pesurya Thu, 10/26/2023 - 14:05 Tue, 12/05/2023 - 11:00 Resource Type Webinar Julie Bullock, PharmD Krithika Shetty, PhD Blaire Osborn, Ph.D. png Listing Introduction Clinical pharmacology information comprises more than 50% of a drug label.

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Alta Sciences

FEBRUARY 8, 2024

In this on-demand webinar, Ingrid Holmes , Vice President of Global Clinical Operations at Altasciences, and Dr. Gary G. President of Cognitive Research Corporation , examine simple and cognitive domains in clinical and pharmacology studies, including analysis of driving impairment.

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Clinical Trials Trials Clinical Pharmacology Clinical Development 52

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Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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Agency IQ

JUNE 2, 2023

Title Type Comments Close Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the Federal Food, Drug, and Cosmetic Act Guidance June 5 Patient Preference Information—Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in (..)

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FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)

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FDA Science Regulations Production 40

Agency IQ

SEPTEMBER 29, 2023

Start Date End Date Event Event Type Center 09/27/2023 09/28/2023 13th Annual Global Summit on Regulatory Science Summit National Center for Toxicological Research 09/27/2023 09/27/2023 Cellular, Tissue, and Gene Therapies Advisory Committee Advisory Committee Meeting CBER 09/28/2023 09/28/2023 Electronic Drug Registration and Listing (eDRLS) Using (..)

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FDA Science Regulations Production 40

Alta Sciences

JULY 25, 2024

TOP CLINICAL SCIENTIFIC RESOURCES Webinar: CNS-Active Compounds—The Importance of Cognitive and Pharmacodynamic Testing During First-in-Human Trials Pharmacodynamic (PD) and cognitive testing is used to characterize CNS profiles of novel drugs in order to provide vital data on safety and proof-of-concept (POC) endpoints.

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