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Clinical Research Solutions
Job Description The Weinberg Group, the leading FDA consultancy, is growing and looking for regulatory professionals of all levels to join our staff. Successful candidates will have at least a...
Clinical Research Solutions
Job Description Great opportunity for someone looking to launch their career in the sales or administrative fields! Prior experience is not required, but may be helpful. The Weinberg Group, the...
Clinical Research Solutions
Job Description The Weinberg Group, the leading FDA consultancy, is expanding and seeking an experienced CMC professional to add to our existing capabilities. Qualified candidates must have at least...
Clinical Research Solutions
According to a recent study by JAMA Internal Medicine, the use of surgical mesh for the treatment of pelvic organ prolapse (POP) has decreased after a “strongly” worded severe safety alert was...
Clinical Research Solutions
FDA’s Center for Tobacco Products (CTP) is seeking up to six regulated tobacco manufacturers to participate in a voluntary pilot program to help evaluate a potential new eSubmission portal (CTP...
Clinical Research Solutions
On Tuesday, February 16th, the FDA announced the publication of “Completeness Assessments for Type II API DMFs Under GDUFA,” a final guidance that will help generic drug makers with the preparation...
Clinical Research Solutions
FDA will hold a public workshop in early April to discuss a proposed pilot program to enhance the safety and security of the pharmaceutical distribution supply chain. During this workshop, the Agency...
Clinical Research Solutions
Last week, we provided you with details on FDA’s recommendations for describing display devices in 510(k) premarket submissions. Did we leave you wanting more? Well if you were wishing for additional...
Clinical Research Solutions
On February 9, 2016, the FDA published a draft guidance entitled “Display Devices for Diagnostic Radiology.” The document, which will replace a 2008 guidance (“Display Accessories for Full-Field...
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...