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Clinical Research Solutions
On Tuesday, May 30th, Indivior Plc., a British company focused on addiction treatment, submitted a New Drug Application (NDA) to the FDA for its investigational drug intended to treat...
Clinical Research Solutions
On Tuesday, May 23rd, the FDA granted accelerated approval to Merck & Co.’s Keytruda® (pembrolizumab), a product to treat cancers with a specific genetic feature (also known as a biomarker)....
Clinical Research Solutions
Data integrity has recently been in the agency spotlight. In part because of the draft data integrity guidance issued April 2016, but primarily due to an increased number of inspection findings...
Clinical Research Solutions
Anyone who was on social media in the summer of 2014 knows what the Ice Bucket Challenge was. Videos of people completing the challenge littered most people’s social media feeds, all in hopes of...
Clinical Research Solutions
According to a recent study published in The BMJ, people who take nonsteroidal anti-inflammatory drugs may have a higher risk of suffering from myocardial infraction (i.e., a heart attack) than...
Clinical Research Solutions
On Monday, May 1st, the FDA approved Imfinzi™ (durvalumab). Imfinzi is manufactured by AstraZeneca, and it is a PD-L1 inhibitor indicated for the treatment of patients with locally advanced or...
Clinical Research Solutions
On Thursday, April 27th, the “Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act was reintroduced by members of the Senate & House Judiciary Committees. The CREATES Act is a...
Clinical Research Solutions
The landscape of clinical trials is evolving. The changes that are happening are due to the increased number of FDA-regulated trials, as well as a rise in the complexity of clinical protocols. As...
Clinical Research Solutions
On Thursday, April 27th, the FDA announced the approval of Brineura™ (cerliponase alfa). Brineura, manufactured by BioMarin International Ltd., is an infusion indicated for the treatment of...
Clinical Research Solutions
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
Clinical Research Solutions
Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...
Medical Information
Patient Support Programs (PSPs) in the pharmaceutical sector offer a range of services to help patients start and adhere to their therapies, including Patient Assistance Programs (PAPs), patient...
Clinical Research Solutions
What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...
Regulatory Sciences
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...
Regulatory Sciences
This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...