Conversations in Drug Development Trends

JUNE 21, 2024

The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. Interested in hearing more insights from Matt?

Clinical Trials 64

Clinical Trials Clinical Research Immune Response Therapies 64

PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). Transitioning to EU CTR requirements for existing studies Under the regulation, clinical trial applications submitted before Jan.

Clinical Trials 52

Clinical Trials Regulations Trials Pharmaceutical Companies 52

Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Read AgencyIQ’s analysis of a lower court’s ruling.

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic.

Regulations 40

Regulations Trials Science Clinical Trials 40

Agency IQ

MARCH 1, 2024

In this piece, AgencyIQ explains what a government shutdown would mean for FDA’s regulatory processes and for the industry it regulates. In November, Congress passed a short-term CR that extended some federal funding (at current levels) through March 1, 2024. What is happening now? What does a shutdown mean for the FDA?

Government 40

Government FDA Biosimilars Regulations 40

Agency IQ

FEBRUARY 12, 2024

BY RACHEL COE, MSC | FEB 7, 2024 10:21 PM CST The Bespoke Gene Therapy Consortium A collaborative effort, the Bespoke Gene Therapy Consortium (BGTC) was launched in October 2021 to “accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease.”

FDA 40

FDA Therapies Clinical Trials Virus 40

Drug Discovery World

JULY 1, 2024

Together, this research aims to generate evidence for advising and guiding future parents before and during pregnancy. He thinks that the amount of money awarded in total is unique for research in this very specific field and that the research projects complement each other and the international research in this field.

Disease 163

Disease International Research Science 163

Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. The agency also issued three updated guidances to help sponsors prepare.

FDA 40

FDA Production Regulations Vaccine 40

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. This is what OIRA is currently reviewing.

FDA 40

FDA Science Regulations Production 40

FDA Law Blog: Drug Discovery

JULY 9, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & Sarah Wicks & Deborah L. The deadline for the Draft Guidance was December 29, 2023, so the draft, issued on June 26, 2024, is about 6 months late under FDORA’s mandate. 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)).

FDA 59

FDA Clinical Trials Disease Trials 59

Agency IQ

FEBRUARY 2, 2024

BY KIRSTEN MESSMER, PHD, RAC, KARI OAKES | JAN 31, 2024 9:01 PM CST Regulatory Background Cancer is the second leading cause of death in the E.U. The European Commission also implemented its Mission on Cancer , which aims to further cancer research and innovation through funding in the same areas as the cancer plan. were from cancer.

Clinical Trials 40

Clinical Trials Trials Treatment Production 40

Broad Institute

JANUARY 24, 2024

Terra is now generally available on Microsoft Azure By Allessandra DiCorato January 24, 2024 Breadcrumb Home Terra is now generally available on Microsoft Azure Terra on Microsoft Azure expands support for enterprises and data scientists across the globe. health system customers and Data Processor Agreements for customers regulated by GDPR.

Compliance 140

Compliance Bioinformatics Science Research 140

Agency IQ

FEBRUARY 21, 2024

Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform Although individual regulators are increasingly adopting online, cloud-based approaches to interface with sponsors, there’s been no centralized cloud platform to support efficient submissions to multiple regulators.

Science 40

Science Regulations International FDA 40

Agency IQ

MAY 28, 2024

BY RACHEL COE, MSC | MAY 23, 2024 7:12 PM CDT Yesterday’s Energy & Commerce Health Subcommittee Hearing All three of FDA’s medical product center directors appeared before the Health Subcommittee of the U.S. Read AgencyIQ’s analysis of the rule here.] Thank you. I appreciate it.” NEAL DUNN (R-Fla.).

FDA 40

FDA Production Science Clinical Trials 40

Agency IQ

JUNE 28, 2024

BY LAURA DIANGELO, MPH | JUN 26, 2024 8:17 PM CDT Quick background: FDA’s work to advance clinical trial diversity through prospective planning The FDA has longstanding policy interests focused on research study diversity. In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs.

FDA 40

FDA Science Clinical Trials Production 40