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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Clinical Pharmacology Drug Development Regulations Marketing 52

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.

Clinical Trials 52

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Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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FDA Science Regulations Clinical Trials 40

Agency IQ

FEBRUARY 2, 2024

Start Date End Date Event Event Type Center 01/10/2024 01/10/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Bringing Innovation to People Facing Cancer” Webcast Office of the Commissioner 01/26/2024 01/26/2024 Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) (..)

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FDA Science Regulations Clinical Trials 40

Agency IQ

MARCH 1, 2024

Start Date End Date Event Event Type Center 02/26/2024 02/26/2024 FDA/CDER and American Association of Pharmaceutical Scientists (AAPS) Hybrid Public Workshop Public CDER 02/27/2024 02/27/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer, Black History Month Program: “Real Talk: Our Stories as Black Oncologists at the FDA” Webcast (..)

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FDA Science Clinical Trials Regulations 40

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 40

FDA Science Regulations Production 40

Agency IQ

JUNE 2, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., These inspections will be routine surveillance rather than inspections as part of an approval application.

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FDA Science Regulations Production 40