Rising Proportion of New and Modified Indication Approvals
Applied Clinical Trials
Tufts Center for Drug Development
In an effort to extend product life cycles and generate larger and longer revenue streams per product, pharmaceutical and biotechnology companies have stepped up their efforts to seek approval for new or modified indications of already approved drugs.
A recent study conducted by the Tufts Center for the Study of Drug Development finds that the number of new or modified indication approvals following the original new drug approval (NDA) increased 17% between the periods 1998 to 2003 and 2004 to 2009. Original NDAs as a proportion of total drug approvals continues to decline gradually. The number of new drug approvals for pediatric indications following original NDAs rose sharply, increasing 107% between 1998 and 2009. The number of NDA new indications increased 15%, and the number of supplemental NDA new indications declined 5% during this period. Anti-infective and CNS drugs each accounted for one-fifth of all new or modified indication approvals between 1998 and 2009. Cardiovascular and oncology drugs accounted for 15% and 13% of all new or modified indications respectively. Moving forward, with finite resources, sponsors must strike the right balance in maximizing portfolio value by allocating R&D resources between novel, original NDAs, and new or modified indication approvals.
—Tufts Center for the Study of Drug Development, http://csdd.tufts.edu.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Funding Cuts Threaten Diversity in Clinical Research
June 27th 2025In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how recent federal funding cuts are likely to undermine research focused on underrepresented populations, and why long-term investment in community-based studies is essential to closing persistent health equity gaps.
