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Clinical Research Solutions
Final Guidance July 2022 This guidance is intended to assist sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications...
Clinical Research Solutions
Final Guidance July 2022 This guidance provides recommendations to clinical investigators and sponsors regarding the inclusion of patients who have not received available therapy (commonly referred...
Clinical Research Solutions
July 2022 As part of FDA’s continued efforts to improve transparency and provide helpful information to regulated industry and the public, the agency is issuing two final guidances for generic drug...
Clinical Research Solutions
What is ILAP? What benefits does ILAP provide? How do you access it? With the dust of Brexit settling, the question on most people’s lips (well, those of us in the healthcare sector anyway!) was:...
Clinical Research Solutions
Draft Guidance July 2022 This guideline provides recommendation to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical...
Clinical Research Solutions
Draft Guidance July 2022 This guidance is intended to assist applicants in incorporating dose banding information into the drug labeling provided in a new drug application (NDA) submitted under the...
Clinical Research Solutions
What it is, why it matters, how you can apply and how we can help. What is the PRIME Scheme? You might be forgiven if you don’t know what the PRIority MEdicines (PRIME) scheme is; but if you are in...
Clinical Research Solutions
FDA Draft Guidance July, 2022 As part of the FDA’s continued efforts to provide helpful information to regulated industry and the public, the agency has published a draft guidance for industry,...
Clinical Research Solutions
EMA Pre-authorisation guidance Table of contents 1. Types of applications and applicants 2. Steps prior to submitting the application 3. Preparing the dossier 3.1 Product name, product information...
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...