Comparator drugs stay on the critical path of most clinical trials. If the comparator is late, in short supply, or lacks the right paperwork, the study stalls. That makes choosing a comparator sourcing partner one of the most important supply decisions a sponsor or CRO will make. This blog covers why reliable comparator drug sourcing…

September 2026 brought 9 new FDA drug approvals, spanning rare neurological diseases, oncology, diabetes, diagnostic imaging, and movement disorders. These approvals introduce new treatment options and highlight potential opportunities around market growth, exclusivity timelines, and future filing strategies for pharmaceutical companies. Each new approval also brings potential future requirements for comparator and RLD sourcing, as…

Most conversations about clinical trial supply start with the same question: Will the investigational product or comparator drug reach the site on time? The drug is central to the study, and any disruption to its supply can have serious consequences. But the drug is only one part of what a clinical site needs to keep…

The FDA approved 7 new drugs in August 2026. These approvals introduced new treatment approaches across sleep disorders, Alzheimer's disease diagnostics, oncology, rare diseases, autoimmune conditions, and hematology. For pharma companies, each approval can signal future opportunities around market entry, exclusivity timelines, and filing strategies. These approvals may also create future requirements for comparator sourcing,…

Comparator sourcing is one of the most consequential decisions in trial design. Get it wrong, and the results become hard to interpret, regulators question the design, or the supply team cannot get the product in time. Comparator drug, active comparator, and placebo are often used as if they mean the same thing. They don't. Each…

Salim Shaikh, Founder and CEO of Spring Bio Solution, has authored a new article, "The Intelligence Gap in Comparator Sourcing: Why Clinical Trial Teams Are Still Flying Blind". This article examines one of the most costly yet overlooked problems in clinical research: the disconnect between comparator sourcing intelligence and trial design. Sponsors invest millions in…

6 new drugs were approved by the FDA in the month of July. These drugs created new opportunities across oncology, immunology, cardiovascular care, ophthalmology, and CNS therapies. They hint at new market opportunities, exclusivity timelines, and potential filing strategies for the decision-making teams. Each new approval also signals a future comparator & RLD sourcing requirement,…

A drug can look brilliant in a single-arm study and fail completely once placed head-to-head against an active control. That gap between apparent effect and real effect is the entire reason controlled clinical trials exist. Most participants improve for reasons that have nothing to do with the investigational product. Disease states fluctuate. Trial participants often…

High-value oncology drugs often come with equally complex clinical supply requirements. OGSIVEO® (nirogacestat) is one such example. Approved by the U.S. FDA on November 27, 2023, OGSIVEO became the first approved treatment to transform nearly 30 years of desmoid tumor management. Where surgery was once the primary treatment option despite recurrence rates approaching 77%, OGSIVEO…

Every few months, someone in a regulatory affairs forum asks a version of the same question: does rolling review actually save time, or does it just move the same amount of work earlier? It's a fair thing to wonder as the term gets used loosely. Some people confuse it with priority review. Others assume it…