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Clinical Research Solutions
In the new guidance on substances that can be added to foods, including beverages and dietary supplements, the FDA reminds manufacturers that the excipients added to oral dosage forms of these...
Clinical Research Solutions
We saw in Part 1 of this series how a confidence interval can be calculated to define a range within which the true value of a statistical parameter such as a mean or standard deviation is likely to...
Clinical Research Solutions
In a Federal Register notice published today, the Food and Drug Administration (FDA) announced its intention to take enforcement action against misbranded or unapproved prescription products...
Clinical Research Solutions
If enforcement against pharmaceutical companies for off-label promotion by the Office of Inspector General (OIG) and the Department of Justice (DOJ) and the Food & Drug Administration (FDA) were not...
Clinical Research Solutions
The Food and Drug Administration (FDA) recently published a draft guidance that outlines the “Naming of Drug Products Containing Salt Drug Substances” in accordance with the recently implemented USP...
Quality & Compliance
If you have been following along, you now know that I have reviewed the first three gates to the Nine Gate Transfer Process for moving production from site to site. I have covered: Gate 1: Assessment...
Clinical Research Solutions
The Food and Drug Administration (FDA) may soon be cracking down on compounding pharmacies according to a recent bill introduced in the United States Legislature. The bill (Drug Quality and Security...
Clinical Research Solutions
The concepts detailed in ICH Q10, Pharmaceutical Quality Systems (PQS) are commonly understood and are progressively being employed in modern quality management systems. The intent of the PQS...
Clinical Research Solutions
In a Federal Register notice to be published on Dec. 10, 2013, FDA announced the release of a new guidance titled “Size, Shape and Other Physical Attributes of Generic Tablets and Capsules.” The...
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...
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...
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...
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...
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...
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...