On Tuesday, September 25th, the FDA issued a guidance document entitled “ANDA Submissions – Content and Format.” The document, initially issued as a draft guidance in June 2014, provides sponsors...
On Tuesday, September 11th, FDA granted two de novo classification requests for mobile medical applications to be used with the Apple Watch. ECG App The first app, referred to as the ECG app,...
On Thursday, September 13th, FDA published a proposed rule which would amend the current premarket submission requirements for medical devices. Background In July 2012, the Food and Drug...
On Thursday, August 16th, the FDA released a list of medical device accessories that have the potential to be reclassified as class I devices. Background According to section 513 of the Food, Drug, &...
On Monday, August 6th, FDA released a new draft guidance on clinical endpoints for demonstrating effectiveness of drugs for medication-assisted treatment for opioid use disorder (OUD), entitled...
On Friday, August 3rd, the FDA released a new draft guidance regarding nonclinical testing of orally inhaled nicotine-containing drug products. The draft guidance focuses on providing the nonclinical...
According to a recently released notice from the FDA, “the FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a re-inspection fee for...
On Wednesday, August 1st, FDA released a notice with updated prescription drug user fee rates for fiscal year 2019. Prescription Drug Application Fees According to the Food, Drug, & Cosmetic (FD&C)...
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...
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...
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...
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...
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...