The electronic common technical document (eCTD) is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and the Center for…
Read More
Today, the cost of developing a new drug is higher than ever, driven in large part by improperly designed, untimely, or unnecessary clinical studies. Companies pour money into a development…
Read More
by Scientific Writing Team Does my product require an Investigational New Drug (IND) application? It’s a simple question, but the answer can have extensive consequences for your development program. In…
Read More
One of the most important aspects of any drug development program is the stream of interactions with regulatory authorities like the US Food and Drug Administration (FDA). These interactions can…
Read More
Immuno-oncology is an exciting but challenging subspecialty that falls underneath the umbrella of oncology research and development. Unlike more traditional oncology treatments that target the tumor itself (albeit sometimes rather…
Read More
Until the early 1980s, developing therapeutics to treat rare diseases was most often a money-losing endeavor due to high cost of development and small patient populations that these products would…
Read More
Study design and subject safety are of the utmost importance in a Phase 1 study. It is also important to be wary of pitfalls as you plan your clinical trial.…
Read More