FDA

Outdated regulations and inflexible sponsor processes are hampering clinical trial recruitment, but empowering sites with modern, compliant marketing tools could turn the tide.

As clinical research increasingly relies on RWD to enhance trial design and patient insights, tokenization has emerged as a critical solution for securely linking disparate datasets while protecting patient privacy.

Under the new initiative, companies may receive a voucher enabling FDA review to be shortened from the standard 10–12 months to just 1–2 months following final application submission if the drug addresses US national health priorities.

While randomization is required by regulatory bodies, it is up to the sponsor on how to conduct it.

In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.

Rinvoq (upadacitinib) becomes the first oral JAK inhibitor approved by the FDA for the treatment of giant cell arteritis in adults, following robust data from the Phase III SELECT-GCA trial demonstrating its efficacy in achieving sustained remission and reducing glucocorticoid exposure.

FDA grants Priority Review status to Sanofi's tolebrutinib for the treatment of non-relapsing secondary progressive multiple sclerosis based on positive findings from multiple Phase III trials.

In an interview with ACT senior editor Andy Studna at SCOPE Summit, Rajneesh Patil, vice president, digital innovation, IQVIA, highlights the impact of artificial intelligence/machine learning in improving outcomes and maintaining safety with its implementation.

Recent actions by the FDA and NIH in response to the current political climate have left key stakeholders in clinical trials with limited resources to conduct equitable research.

Study finds the typical cost of clinical research for developing new drugs is lower than previously estimated, with median costs providing a more accurate reflection than mean costs.

In this video interview, Rachael Fones, director, government & public affairs, IQVIA, discusses the importance of goal setting in the context of FDA’s latest Diversity Action Plan guidance.

Industry leaders share their perspectives on the guidance and how it will affect sponsors moving forward.

In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discusses how the guidance should prompt better-designed oncology trials and greater diversity.

In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, touches on challenges that may be created by the guidance such as meeting multiple regulatory requirements.

In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discusses how sponsors will need to plan ahead even further for their oncology trials.

In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, highlights how FDA’s multiregional clinical trials in oncology guidance encourages more diverse site locations and patient populations.

In this video interview with ACT editor Andy Studna, Kashoki, SVP, global head of regulatory strategy, discusses the new draft guidance and its emphasis on proactive planning.

Final guidance suggests sponsors select two doses for Phase II trials with additional data requirements.

In part 2 of this conversation, Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses the guidance and how it will affect sponsors moving forward.

Del Smith, PhD, co-founder & CEO of Acclinate highlights challenges sponsors may face in light of FDA releasing its Diversity Action Plan guidance.

Smith shares his initial thoughts on the guidance and what its impact will be on the industry moving forward.

Pamela Tenaerts, MD, MBA, chief scientific officer, Medable; Luke Gelinas, PhD, senior chair director, Advarra; and Pam Diamond, MD, chief medical officer & co-founder, Curavit highlight the potential impact FDA's Diversity Action Plan guidance will have on industry.

Pamela Tenaerts, MD, MBA, chief scientific officer, Medable; Luke Gelinas, PhD, senior chair director, Advarra; and Pam Diamond, MD, chief medical officer & co-founder, Curavit share their initial thoughts on the announcement of FDA's Diversity Action Plan guidance.

In an interview with ACT editor Andy Studna at DIA 2024, Beakes-Read, head, global regulatory policy and intelligence, Johnson & Johnson Innovative Medicine highlights the integration of technological advancements into drug development and benefits patients are seeing from FDA's Accelerated Approval Program.

Johnson & Johnson is moving forward with a pair of Phase III trials of nipocalimab to reduce the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.

Odronextamab is being evaluated for the treatment of relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma following two or more prior lines of systemic therapy.

Pivotal Phase III Study 302 trial data show an objective response rate of 36.2% based on an independent review committee assessment in the treatment of relapsed/refractory cutaneous T-cell lymphoma.

The FDA previously halted the IOV-LUN-202 trial following reports of a grade 5 serious adverse event that may have been linked to treatment with Iovance Biotherapeutics’ novel tumor infiltrating lymphocyte cell therapy LN-145, which is being evaluated in patients with advanced non–small cell lung cancer.

Epkinly (epcoritamab-bysp), subcutaneously administered, T-cell engaging, IgG1-bispecific antibody, was previously granted Breakthrough Therapy Designation for the treatment of patients with relapsed or refractory follicular lymphoma.

Trial data show Dupixent rapidly and significantly improved lung function compared to placebo in adults with uncontrolled chronic obstructive pulmonary disease with type 2 inflammation.