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Clinical Research Solutions
On Thursday, June 8th, the FDA requested that Endo Pharmaceuticals remove Opana® ER (oxymorphone hydrochloride), an opioid pain medication, from the market. History with FDA The FDA originally...
Clinical Research Solutions
On Thursday, June 1st, the FDA issued a Warning Letter to Prestige Brands Holdings, an over-the-counter (OTC) drug manufacturer. PediaCare Children’s Plus Multi-Symptom Cold and PediaCare Children’s...
Clinical Research Solutions
On Wednesday, June 7th, the FDA amended its final rule concerning humanitarian use devices (HUDs). The amendments to the regulations are being made in response to changes recently enacted into law by...
Clinical Research Solutions
On Tuesday, May 30th, Indivior Plc., a British company focused on addiction treatment, submitted a New Drug Application (NDA) to the FDA for its investigational drug intended to treat...
Clinical Research Solutions
On Monday, May 22nd, the FDA issued a warning for drug manufacturers regarding the contamination risk posed by Burkholderia cepacia complex (BCC). According to FDA’s warning, “BCC and other...
Clinical Research Solutions
On Tuesday, May 23rd, the FDA granted accelerated approval to Merck & Co.’s Keytruda® (pembrolizumab), a product to treat cancers with a specific genetic feature (also known as a biomarker)....
Clinical Research Solutions
Data integrity has recently been in the agency spotlight. In part because of the draft data integrity guidance issued April 2016, but primarily due to an increased number of inspection findings...
Clinical Research Solutions
Anyone who was on social media in the summer of 2014 knows what the Ice Bucket Challenge was. Videos of people completing the challenge littered most people’s social media feeds, all in hopes of...
Clinical Research Solutions
According to a recent study published in The BMJ, people who take nonsteroidal anti-inflammatory drugs may have a higher risk of suffering from myocardial infraction (i.e., a heart attack) than...
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...