One of the most common formulation issues that sponsors of new drug or biologic products face is the qualification of novel excipients. Although novel excipients can be a part of any new drug application (NDA) or biologics license application (BLA)...
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Research and development (R&D) investment decisions may be the largest risk taken by drug developers. When a single asset has broad applicability, sponsors must perform a thorough evaluation of its scientific, regulatory, clinical, patient, and commercial elements to determine the...
With the promise of simplified and improved treatments, the $118 billion combination-product market is projected to increase at a compound annual growth rate (CAGR) of 8.8%. Working to bring these valuable new therapies to patients, sponsors engaged in strategic development...
A key challenge of developing therapies for rare diseases is the availability of relevant data. With small, often geographically-dispersed patient populations, natural history information is typically sparse or even unknown. Without this data, it may be difficult to identify biomarkers...
During the development cycle of a regulated therapeutic, the transfer of the manufacturing process is inevitable. The process will be transferred from the development lab to a pilot or small-scale manufacturing facility and, if the program is successful, to a...
The Marketing Authorization (MA) holder for a treatment for onychomycosis, having previously secured regulatory approval in several markets, sought to introduce the product to the European market. Completion of the Marketing Authorization Application (MAA) required utilization of the Active Substance...
Clinical trials for ultra-rare diseases can be particularly challenging to mount due to small, geographically-dispersed patient populations. For such trials, the US Food and Drug Administration (FDA) may allow the use of credible real-world data (RWD) and real-world evidence (RWE)...
The technology transfer of a manufacturing process to a contract development and manufacturing organization (CDMO) is a key step on the road to developing and commercializing biopharmaceutical products. Successfully executing this step is critical to clearing regulatory expectations, avoiding production...
A quality electronic Trial Master File (eTMF) is essential to the product development and approval process, as it is the foundation for clinical trial inspections by competent authorities. eTMFs for drug, biologic, and medical device trials should be actively managed...
Before the 2012 Food and Drug Administration (FDA) Nonprescription Safe Use Regulatory Expansion (NSURE) initiative, sponsors were transitioning prescription drugs (Rx) to over-the-counter (OTC). Streamlined access to effective treatments clearly benefits patients and payers. At the same time, easier access...