Key Takeaways from this article — Amyotrophic Lateral Sclerosis (ALS) affects approximately 30,000 Americans at any given time, with about 5,000 new diagnoses each year in the US alone. — The global ALS treatment market is in an active growth phase, driven by genetic stratification, biomarker-enabled trials, and a first genotype-specific approval in 2023. — […]
Read More →For anyone seeking generic drug approval in the USA, a Bioavailability and Bioequivalence (BA/BE) study is often a critical step. These studies show the FDA that your product works just like the approved brand-name version, meeting strict guidelines for safety and effectiveness. Choosing the right global location for your trial, managing costs, and ensuring the […]
Read More →The clinical research landscape is shifting drastically due to an increase in the availability of electronic data allowing researchers to make assessments based on available real-world evidence (RWE) obtained from the analysis of real-world data (RWD). Global regulators are encouraging researchers/drug developers utilize the RWE for submissions. Many regulators are accepting the Real-world evidence (RWE) […]
Read More →Oncology trials are more complex than trials in any other therapeutic area. Research in oncology differs in terms of trial design, trial types, the role of a comparator, treatment outcomes, adverse event reporting, interpreting the results, and more. Developing a well-defined clinical development strategy for oncology clinical trials is crucial due to the significant costs, […]
Read More →Do you know, according to clinicaltrials.gov, a total of 354,130 clinical trials were registered worldwide with 71,256 ongoing clinical trials as recorded on Oct-2020? The number of clinical trials is increasing year by year from 56.16k in 2017 to 60.69k in 2018. In the USA, more than 2.3+ million people participate in approximately 80,000+ clinical […]
Read More →Clinical trials in rare diseases present more significant challenges compared to trials in more common diseases. These challenges arise due to various factors, including trial design, the limited patient population for recruitment, regulatory support, and more. However, implementing a well-defined strategy for clinical development in rare diseases can help overcome these challenges. Such a strategy […]
Read More →Drug development is a lengthy, complex, and costly process entrenched with a high uncertainty that a drug will successfully reach the market. So for this, you need a proper drug development strategy to avoid uncertainties and complete clinical trials in time with quality data. Drug development is the process to bring a new pharmaceutical drug […]
Read More →Drug development is the process of bringing a new pharmaceutical drug to the market after identifying a lead compound through drug discovery. The drug development process starts from drug discovery and ends gaining market approval and post-marketing studies, This entire process of medical device/drug development takes years and depends on many factors such as Type […]
Read More →The United States remains the largest medical device market in the world with $156 billion which is 40 percent of the global medical device market in 2017 and By 2023, it is expected to grow to $208 billion The medical technology industry (commonly referred to as medical devices) consists of articles, instruments, apparatuses, or machines […]
Read More →This article is a sequence of the Regulatory & Drug Approval Process in the United States, Part-I, which describes the Investigational New Drug (IND) approval process, New Drug Approval (NDA), and Generic drug approval process. In this article, we will discuss the market approval process of biologics, biosimilars, orphan drugs, and various drug approval pathways. Which is the regulatory authority […]
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