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Clinical Research Solutions
In February 2000, FDA released a draft guidance entitled “Formal Dispute Resolution: Appeals Above the Division Level” which established procedures for resolving scientific and procedural disputes...
Clinical Research Solutions
FDA has accepted for review the first NDA for a “digital” medicine product. The product, which is produced by Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health, is the first-ever medication...
Clinical Research Solutions
Following the release of an analytical report published by ProPublica, the House of Representatives is seeking more information regarding the safety of Coumadin, a widely-prescribed blood thinner,...
Clinical Research Solutions
The FDA’s announcement this summer that it would take enforcement action against several unapproved formulations of ear drops provides a great opportunity for a pharmaceutical company that would like...
Clinical Research Solutions
Recently, FDA published a guidance (entitled “Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products”) providing sponsors with recommendations on how...
Clinical Research Solutions
As we noted a few weeks ago, Duchesnay, the company that manufactures prescription morning sickness medication Diclegis, received a warning letter from FDA after Kim Kardashian posted a "selfie" on...
Clinical Research Solutions
Last week, FDA announced the highly anticipated guidance, along with a proposed rule, which will establish a naming convention for biological products, including both related and biosimilar products....
Clinical Research Solutions
Earlier this year, FDA published a report announcing that the Agency’s device program has shown “a pattern of markedly improved performance.” Over the past five years, FDA has been working to improve...
Clinical Research Solutions
Last month, FDA published a draft guidance titled “Request for Quality Metrics,” which outlined the ways in which it intends to collect and use quality metrics. The guidance states that the data will...
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...