Conversations in Drug Development Trends

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. However, patients also play a vital role in engaging directly with the FDA. Her fellow panelists represented a diverse group of stakeholders across clinical research, including patient advocates, sponsors, sites, and the FDA itself.

FDA 96

FDA Trials Clinical Trials Disease 96

Advarra

SEPTEMBER 19, 2024

Achieving diversity, equity, and inclusion (DEI) in clinical trials is crucial for producing comprehensive and effective medical research benefitting all communities. DEI ensures clinical research encompasses diverse populations, considering variations in gender, race, ethnicity, socioeconomic status, and more.

Clinical Research 52

Clinical Research Research Clinical Trials Trials 52

Conversations in Drug Development Trends

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Food and Drug Administration (FDA) Parallel Scientific Advice procedure, which aims to increase dialogue between the two agencies and sponsor companies.

Clinical Research 69

Clinical Research Trials Clinical Trials Research 69

Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

Clinical Research 52

Clinical Research Research Compliance Clinical Trials 52

Vial

DECEMBER 4, 2023

Clinical research is an integral component of the healthcare ecosystem. The success of clinical research hinges crucially on patient participation; however, attracting and retaining participants can often pose significant challenges. Patient Payments in Clinical Research: Perception Over the Years In the U.S.,

Clinical Research 52

Clinical Research Research Clinical Trials Regulations 52

Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline.

Clinical Research 52

Clinical Research Clinical Trials Research Trials 52

Drug Target Review

APRIL 7, 2025

While biomarkers are increasingly being adopted as surrogate endpoints by the US Food and Drug Administration (FDA), advances in biomarker detection also present a variety of regulatory challenges related to the complexities in their selection, implementation and clinical interpretation. References FDA-NIH Biomarker Working Group.

Clinical Development 69

Clinical Development Clinical Trials Clinical Pharmacology Trials 69

H1 Blog

JULY 30, 2024

Diversity Action Plans (DAPs) aim to improve data that the FDA receives by increasing the clinical enrollment of historically underrepresented participants. The recent draft by the FDA introduces additional guidelines for Diversity Action Plans aimed at improving diversity in clinical research.

FDA 59

FDA Clinical Trials Compliance Pharma Companies 59

thought leadership

SEPTEMBER 26, 2024

On May 6, 2024, the US Food and Drug Administration (FDA) issued the Final Rule regarding regulation of laboratory developed tests (LDTs). The LDT Final Rule outlines a four-year phaseout period for the enforcement discretion approach that FDA has previously exercised for LDTs.

FDA 58

FDA Laboratories Regulations Drugs 58

Fierce BioTech

OCTOBER 14, 2024

To comply with the 21st Century Cures Act,1 the Food and Drug Administration (FDA) has released two Notices of Proposed Rulemaking (NPRMs). | The impending sIRB mandate will impact all clinical research stakeholders. Prepare for it with WCG’s expert guidance.

FDA 52

FDA Clinical Research Research Drugs 52

Conversations in Drug Development Trends

NOVEMBER 5, 2024

In preparation for World Orphan Drug Congress Europe, we interviewed Nathan Chadwick, Senior Director, Therapeutic Strategy Lead, Rare Disease, and Derek Ansel, MS, LCGC, Vice President, Therapeutic Strategy Lead, Rare Disease, to hear their insights into the current progress in rare disease research and their hopes for 2025.

Disease 52

Disease Clinical Trials Therapies Clinical Research 52

PPD

SEPTEMBER 16, 2024

In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinical research and drug discovery. Food and Drug Administration (FDA) that is expected to continue to rise, it’s critical to find methods that materially help improve disease outcomes.

Clinical Development 98

Clinical Development Clinical Trials Clinical Research Trials 98

Agency IQ

AUGUST 18, 2023

FDA’s informed consent guidance gets a 21st century makeover The FDA has issued a new, final guidance on informed consent for clinical investigations – the first update since 1998. The FDA, HHS, and research and informed consent policies In the U.S., Fill out the form to read the full article.

FDA 52

FDA Clinical Trials Clinical Research Regulations 52

Olympian Clinical Research

MARCH 25, 2019

The FDA has voted to approve SPRAVATO TM (esketamine)! SPRAVATO will offer the first new mechanism of action in 30 years to treat this debilitating disease, continuing Janssen’s 60-plus-year history and commitment to research that make a difference for people living with mental illnesses, including severe mood disorders.” [1].

Clinical Research 70

Clinical Research Clinical Trials Treatment FDA 70

PPD

JUNE 7, 2023

Food and Drug Administration (FDA) for approval , much work remains for drug developers aiming to advance treatments for pediatric populations. Reflecting Patient Diversity in NASH Trials Data from NASH clinical trials within adult populations may support clinical research into treatment for pediatric populations.

Trials 98

Trials Clinical Trials Clinical Research Disease 98

Conversations in Drug Development Trends

NOVEMBER 27, 2023

Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. In recognition of the unmet need and medical urgency for innovative therapies in the sickle cell space, the FDA granted exa-cel Priority Review, with a formal decision expected by December 8, 2023. In June 2023, the U.S.

Treatment 75

Treatment FDA Clinical Trials Therapies 75

Quanticate

MAY 21, 2020

This blog focuses on regulatory writing, which involves the preparation of clinical study and regulatory submission documentation. There are two main areas in medical writing, medical communications and regulatory writing.

Clinical Research 52

Clinical Research Research Clinical Trials FDA 52

The Pharma Data

AUGUST 24, 2020

The FDA could expand its Emergency Use Authorization (EUA) for Gilead’s remdesivir for treating coronavirus patients, according to Gilead. Currently, the FDA guidelines state that the treatment can be given to patients experiencing severe symptoms from coronavirus. Army photo by Jason W.

FDA 52

FDA Government Clinical Research Hospitals 52

PPD

AUGUST 16, 2023

However, as the world settles into its post-pandemic state and returns to pre-pandemic paradigms in many areas, the pharmaceutical industry remains dedicated to moving beyond traditional, centralized clinical trial constructs. Fortunately, leading global regulators have launched key initiatives.

Clinical Trials 98

Clinical Trials Trials Clinical Research FDA 98

Advarra

MARCH 20, 2023

The Food and Drug Administration (FDA) recently released new guidance regarding cellular and gene therapy products, one of which may significantly impact early-phase clinical trials of such products. In all cases, it’s evident the FDA’s interest is in providing sponsors with greater flexibility and improved efficiency in research.

Therapies 52

Therapies FDA Trials Clinical Trials 52

Agency IQ

AUGUST 30, 2024

FDA AdComm to discuss patient-centric informed consent The FDA’s Center for Devices and Radiological Health (CDRH) will soon convene its Patient Engagement Advisory Committee to discuss “patient-centered informed consent” policies – notably, not just for medical devices but for “FDA regulated medical products” writ large.

FDA 40

FDA Regulations Clinical Trials Production 40

The Pharma Data

AUGUST 31, 2021

Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval. 10), as determined by an FDA-approved test, or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

FDA Approval 52

FDA Approval Treatment FDA Research Laboratories 52

ProRelix Research

DECEMBER 28, 2023

Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered […] The post Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management appeared first on ProRelix Research.

FDA Compliance 52

FDA Compliance Clinical Trials Compliance Trials 52

PPD

AUGUST 5, 2024

Food and Drug Administration (FDA)-approved therapies for treating PAH were primarily vasodilators, designed to overcome the imbalance between vasoactive and vasodilator mediators and to restore endothelial cell function. Complexity: PAH trial sites are complex and require highly experienced clinicians, researchers and support staff.

Clinical Trials 98

Clinical Trials Trials Clinical Research Disease 98

The Pharma Data

DECEMBER 16, 2020

Food and Drug Administration (FDA) has approved Benlysta to treat lupus nephritis (lupus-related kidney disease) in adults. The FDA first approved Benlysta for lupus in 2011. This is the most extensive controlled phase 3 study in active lupus nephritis, demonstrating that Benlysta could make a clinically meaningful improvement.

FDA Approval 52

FDA Approval FDA Clinical Trials Treatment 52

Agency IQ

AUGUST 11, 2023

FDA looking to beef up its remote assessments with artificial intelligence According to a new FDA contract notice, the agency is interested in procuring a new artificial intelligence-based Optical Character Recognition system to extract data from PDFs obtained during remote regulatory assessments. What does the FDA want to do, anyways?

FDA 40

FDA Compliance Clinical Trials Pharmacokinetics 40

The Pharma Data

JANUARY 6, 2021

7, 2021 /PRNewswire/ — UNION therapeutics A/S ( UNION ) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults. HELLERUP, Denmark , Jan.

FDA Approval 52

FDA Approval FDA Clinical Development Clinical Research 52

Agency IQ

MARCH 1, 2024

Explainer: What a government shutdown would mean for the FDA (Updated) With Congress again debating the passage of appropriations legislation, the FDA is facing a potential shutdown of operations as of Midnight on March 1. The appropriations bills that expire March 1 include the Agriculture-FDA appropriations bill.

Government 40

Government FDA Biosimilars Regulations 40

Agency IQ

AUGUST 16, 2024

The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways On August 9, Lykos Therapeutics received a Complete Response Letter (CRL) from FDA stating the agency will not currently approve its application for midomafetamine (MDMA) to treat post-traumatic stress disorder.

FDA 40

FDA Trials Therapies Regulations 40

Vial

JUNE 12, 2024

Utilizing PROs enables the active participation of patients in their care outcomes – both in a clinical setting and in clinical research. PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated. For HF, Savarese et al.

Clinical Trials 52

Clinical Trials Trials FDA Clinical Research 52

Agency IQ

DECEMBER 11, 2023

At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation. Fill out the form to read the full article.

Research 52

Research Clinical Research FDA Regulations 52

PPD

NOVEMBER 30, 2023

These shifts are a prelude to further change and progress in the clinical trial landscape in 2024. Food and Drug Administration (FDA) has approved 47 new molecular entities for therapeutic use, already exceeding last year’s progress, which yielded 37 novel drug approvals. This year, the U.S.

Clinical Trials 98

Clinical Trials Trials Clinical Research Drug Development 98

Agency IQ

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation.

FDA 40

FDA Research Clinical Trials Trials 40

Agency IQ

MAY 28, 2024

E&C lawmakers grill directors of FDA medical product centers Wednesday’s House E&C Health Subcommittee Hearing featured an extensive grilling of the leaders of FDA’s three medical products centers: CDER, CBER and CDRH. CBER Director Marks was first to respond on what FDA is doing to track its performance and resources. “I

FDA 40

FDA Production Science Clinical Trials 40

Advarra

JULY 5, 2022

Individuals invest a great deal to participate in clinical research, undertaking risks and burdens, while giving of their time and energies to advance scientific knowledge and the public good. Conversely, a CGM not yet FDA-approved assessed in the study for reliability, would yield an investigational result.

Research 97

Research FDA Approval Packaging FDA 97

Conversations in Drug Development Trends

AUGUST 9, 2024

Advantages and Operational Challenges in Adaptive MRCTs Adaptive trial designs are gaining popularity in clinical research due to their ability to improve trial efficiency and uphold ethical standards, resulting in faster and more reliable outcomes. These include: FDA (U.S.)

Trials 80

Trials Clinical Trials Regulations FDA 80

Advarra

DECEMBER 1, 2022

In the past several years, Health and Human Services (HHS) Office of Human Research Protections (OHRP), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH) have announced and/or implemented new regulations to address the challenges of conducting clinical trials involving multiple research sites.

Regulations 52

Regulations Compliance FDA Clinical Trials 52