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Clinical Research Solutions
After ongoing concern regarding potential overdose in OTC pediatric oral liquid drug products containing acetaminophen, FDA announced the availability of a final guidance earlier this week. Published...
Clinical Research Solutions
As amended by the Prescription Drug User Fee Amendments of 2012, The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess and collect fees from sponsors submitting applications...
Clinical Research Solutions
Under the FD&C Act, FDA is authorized to collect annual establishment and reinspection fees from human drug compounding outsourcing facilities. These fees are collected on an annual basis, and...
Clinical Research Solutions
As required by the Generic Drug User Fee Amendments of 2012, FDA has announced the 2016 rates for the following user fees: Abbreviated new drug application (ANDA), Prior approval to an ANDA (PAS),...
Clinical Research Solutions
Starting in 2002, the FDA began implementing "user fees" in which manufacturers of medical devices wishing to obtain approval from the Agency would pay the pre-specified amount in return for the...
Clinical Research Solutions
computer susteIt’s a Friday afternoon. Quarter’s end. Your V.P. of Regulatory Affairs calls your office bellowing something about not being able to process the latest submission data- can’t access...
Clinical Research Solutions
Business sustainability is an often heard buzz phrase, but how does it apply when a costly process validation is imminent? Process validation is not only a regulatory compliance issue; it is also a...
Clinical Research Solutions
Since the day I entered the industry the mantra of “If you didn’t write it down, it didn’t happen” was repeatedly drilled into my daily mode of operation. The margins of my test sheets were filled...
Clinical Research Solutions
Today, ProPharma Group’s Simona Gherman adds to her series on Media Programs and media fills. Part I of this series was an overview with background information and tips. Part II focuses on what you...
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...