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Clinical Research Solutions
On Tuesday, April 26th, the FDA announced that oral fluconazole (Diflucan) may contribute to increased risk of miscarriage when taken during pregnancy. In its announcement, the Agency stated that it...
Clinical Research Solutions
In mid-April 2016, the FDA published a draft guidance clarifying the role of data integrity in current good manufacturing practice (cGMP) for drug products, as required under 21 CFR parts 210, 211,...
Clinical Research Solutions
Additional information on FDA’s guidance is available in our preceding FDA News article, entitled “Minimizing Medication Errors Related to Product Design, Part One: FDA’s Recommendations for...
Clinical Research Solutions
On September 27, 2007, the Prescription Drug User Fee Act (PDUFA IV) reauthorization and expansion was signed into law, significantly strengthening FDA’s drug safety program. As part of the...
Clinical Research Solutions
On December 23, 2015, the FDA announced a proposed rule regarding the regulation of fixed-combination drugs. In its announcement, FDA proposed that its requirements for prescription fixed-combination...
Clinical Research Solutions
The Drug Supply Chain Security Act (DSCSA), which was signed into law in November 2013, “outlines critical steps to build an electronic, interoperable system” to identify and trace prescription drugs...
Clinical Research Solutions
On Tuesday, April 12, the US House of Representatives approved a bipartisan bill to speed the development of a treatment for the Zika virus. The bill was introduced by US Rep. G. K. Butterfield (D –...
Clinical Research Solutions
In today’s validated lab environment, knowing the importance of an audit trail in computerized laboratory systems is just one of the integral qualification tasks that the ProPharma’s Computer System...
Clinical Research Solutions
FDA kicked off reauthorization negotiations for the Biosimilar User Fee Act (BsUFA) in December 2015, when the first public meeting was held on the subject. More recently, FDA met with various...
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...
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
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...
Medical Information
Patient Support Programs (PSPs) in the pharmaceutical sector represent an array of aimed at supporting patients in initiating therapy and maintaining adherence. PSPs, also known as Patient Assistance...
Clinical Research Solutions
The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded...
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...