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Clinical Research Solutions
On Wednesday, August 1st, FDA released a notice with updated prescription drug user fee rates for fiscal year 2019. Prescription Drug Application Fees According to the Food, Drug, & Cosmetic (FD&C)...
Clinical Research Solutions
On Tuesday, July 31st, FDA released a notice with updated biosimilar user fee rates for fiscal year 2019. The base revenue for FY 2019 is $40,214,000, not adjusted for inflation or operating...
Clinical Research Solutions
On Friday, July 27th, FDA released a notice with updated generic drug user fee rates for fiscal year 2019. Under GDUFA II, user fees should total $493,600,000 each year, adjusted for inflation. The...
Clinical Research Solutions
On Tuesday, July 17th, FDA released a new draft guidance entitled “Innovative Approaches for Nonprescription Drug Products.” The guidance discusses two different approaches for making nonprescription...
Clinical Research Solutions
On Friday, July 13th, FDA approved TPOXX (tecovirimat) for the treatment of smallpox. According to the World Health Organization (WHO), smallpox was eradicated in 1980; however, since eradication...
Clinical Research Solutions
On Friday, July 13th, FDA announced the voluntary recall of several drugs containing the active ingredient valsartan. Valsartan is often used to treat serious medical conditions such as high blood...
Clinical Research Solutions
On Wednesday, July 11th, FDA released six draft guidances to aid in the development of new gene therapies. Of the six guidances, three were disease specific and three were related to manufacturing....
Clinical Research Solutions
According to recent FDA updates on the implementation of the Safety and Innovation Act (FDASIA), nearly 40 percent of finished drugs are being imported, and nearly 80 percent of active ingredients,...
Clinical Research Solutions
On Monday, June 25th, FDA approved GW Pharmaceuticals’ Epidiolex (cannabidiol) for the treatment of two rare and severe forms of epilepsy. Epidiolex is the first FDA-approved drug that contains a...
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...