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Clinical Research Solutions
On Wednesday, February 15th, Senators Michael Bennet (D – CO) and Johnny Isakson (R – GA) introduced a bill to improve FDA’s medical device inspection process. If passed, the bill would amend the...
Clinical Research Solutions
On Tuesday, February 21st, the FDA’s Center for Drug Evaluation and Research (CDER) announced the availability of an updated version of the Purple Book. What is the Purple Book? “The ‘Purple Book’...
Clinical Research Solutions
The desire for a robust and repeatable manufacturing process is shared by every organization that has a therapy or product in development and the only way to demonstrate that this desired state has...
Clinical Research Solutions
In 2013, the FDA released a guidance entitled “Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements.” This guidance was finalized after...
Clinical Research Solutions
In May 2016, the FDA inspected Resonance Laboratories Pvt. Ltd.’s Bangalore manufacturing facility. During this inspection, the FDA investigator observed a number of significant deviations from...
Clinical Research Solutions
In the past two years, the FDA has approved two different types of intragastric balloon systems: Fluid-filled intragastric balloon systems, including the ReShape Integrated Dual Balloon System and...
Clinical Research Solutions
On Monday, February 6th, the FDA released the new process that will be used to collect and post curricula vitae (CVs) for advisory committee members. This will help FDA to post the appropriate CVs to...
Clinical Research Solutions
On Thursday, February 2nd, the FDA issued a safety announcement, warning consumers of rare but serious allergic reactions that have occurred with widely used skin antiseptic products containing...
Clinical Research Solutions
Phase-Appropriate Development and Application of Quality Systems in the Drug Development Process: The Parenteral Drug Association (PDA) recently published a revised version of Technical Report No....
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...