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Regulatory Sciences
On Monday, October 1, FDA’s Center for Biologics Evaluation and Research (CBER) issued a document outlining the policies and procedures for scheduling and conducting INitial Targeted Engagement for...
Clinical Research Solutions
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,...
Clinical Research Solutions
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...
Clinical Research Solutions
On Thursday, September 6th, the FDA released a new draft guidance regarding benefit-risk determinations in medical device premarket approval applications (PMAs), De Novo requests, and humanitarian...
Clinical Research Solutions
In a recent poll conducted by ProPharma Group, the question “What is your biggest GMP auditing challenge?” was posed to Quality professionals in the drug manufacturing industry. The following graph...
Regulatory Sciences
Generic drugs are immensely important to the U.S. healthcare system. These drugs account for 89% of the prescriptions dispensed in the United States. And, over the last decade, generic drugs have...
Clinical Research Solutions
On Monday, August 6th, FDA released a new draft guidance on clinical endpoints for demonstrating effectiveness of drugs for medication-assisted treatment for opioid use disorder (OUD), entitled...
Clinical Research Solutions
On Friday, August 3rd, the FDA released a new draft guidance regarding nonclinical testing of orally inhaled nicotine-containing drug products. The draft guidance focuses on providing the nonclinical...
Clinical Research Solutions
On Monday, July 30th, FDA released the medical device user fee rates for fiscal year 2019. The total FY 2019 revenue amount, prior to adjustments, is $190,654,875. Medical device user fee rates are...
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
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...
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...
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...
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...
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...