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…
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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…
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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…
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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…
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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…
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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.…
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In a previous post, we discussed how combination products are defined in the Code of Federal Regulations, introduced FDA’s Office of Combination Products, and touched on a few unique aspects of how these…
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