Drug Discovery World

NOVEMBER 29, 2022

After just one cohort of students, the Clinical Pharmacology degree at St George’s University has been named the UK’s best pharmacology course. Due to this approach, the Clinical Pharmacology degree has various features that make it different to other courses that are currently available. Starting with the drug.

Clinical Pharmacology 130

Clinical Pharmacology Clinical Trials Drugs Drug Development 130

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Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)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 40

FDA Science Regulations Clinical Trials 40

Agency IQ

FEBRUARY 2, 2024

Title Type Comments Close Digital Health Technologies for Detecting Prediabetes and Undiagnosed Type 2 Diabetes January 31 Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement Meeting February 12 Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Establishment Notice February 12 Advanced Manufacturing (..)

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

Science 40

Science FDA Trials Clinical Pharmacology 40

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 (..)

FDA 40

FDA Science Regulations Compliance 40

Agency IQ

OCTOBER 20, 2023

Biosimilar product developers are expected to conduct foundational analytical studies, animal studies, clinical pharmacology and immunogenicity assessments, and additional clinical evaluations to demonstrate biosimilarity or interchangeability. Read AgencyIQ’s full analysis of the workshop here. ]

Science 40

Science Biosimilars FDA Production 40

Agency IQ

MARCH 1, 2024

A description of the project and summary of outcomes will be posted on the FDA website. primary and secondary).

FDA 40

FDA Science Clinical Trials Regulations 40