Clinical Research Solutions
Year in Review: Taking a Look at Pharma's Top News Stories & Events from 2018
From FDA's approval of the first cannabis-based product in the U.S., to the classification of two Apple Watch apps and changes in the Agency's submission requirements related to Sponsor meetings,...
Innocent Until Proven Guilty: Hypothesis Test
Each of us makes important decisions that shape our lives, every day. We try to make the best decisions possible and yet, as the adage goes "all predictions of the future are wrong, some are just...
Clinical Research Solutions
Outsourcing Functions Doesn't Mean You've Outsourced Compliance Obligations
Over the past 20 years, the traditional approach to drug development has expanded to include the outsourcing of a range of testing and manufacturing functions. As a part of their long-term strategic...
Clinical Research Solutions
Human Subject Protection Regulations: Differences Between HHS’ & FDA’s Clinical Trial Rules
On Friday, October 12th, FDA issued a guidance document entitled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” The document aims to help...
Regulatory Sciences
CBER Provides Sponsors with Policies and Procedures Regarding INTERACT Meetings
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...
Good Review Management Principles & Practices, Part One: Fundamental Values
On Tuesday, September 25th, the FDA published a draft guidance containing recommendations on good review management principles and practices (GRMPs) for new drug applications (NDAs), Biologics...
FDA Releases Draft Guidance on Benefit-Risk Determinations for Devices
On Thursday, September 6th, the FDA released a new draft guidance regarding benefit-risk determinations in medical device premarket approval applications (PMAs), De Novo requests, and humanitarian...
Regulatory Sciences
Generic Failure: Why so Few ANDAs Are Accepted by FDA on the First Pass
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...
Summary Considerations: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers
Here I provide some key summaries and considerations relative to FDA’s draft guidance that was submitted for review and comment in June 2017. If you don’t want to review the entire guidance, here are...
Clinical Research Solutions
Using a Matrix Approach to Media Fills in Sterile Compounding
A survey of FDA Form 483 observations issued to the 503B pharmacy industry reveals that outsourcing compounders are struggling to implement and manage compliant and risk-based approaches to aseptic...
What Should Be on Your Clinical Trial Investigator Site Audit Checklist?
What Should Be on Your Clinical Trial Investigator Site Audit Checklist?: You live and operate in a regulated industry. Obviously, it’s crucial that you stay in compliance during your clinical...
Clinical Research Solutions
How to Write an Effective Quality Investigation Report
In 2016, the FDA issued hundreds of 483 observations across the Drug and Device industries for failing to thoroughly review or investigate issues. This topic consistently hits the top five most...
Clinical Research Solutions
Data Integrity 101: Is your data compliant?
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
Clinical Quality Systems & the Outsourced Model
The landscape of clinical trials is evolving. The changes that are happening are due to the increased number of FDA-regulated trials, as well as a rise in the complexity of clinical protocols. As...
Clinical Research Solutions
The Benefits of Process Characterization in Process Development
The desire for a robust and repeatable manufacturing process is shared by every organization that has a therapy or product in development and the only way to demonstrate that this desired state has...
Regulatory Sciences
Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans
On March 8, 2016, the FDA announced availability of a revised draft guidance for industry regarding pediatric study plans, entitled "Pediatric Study Plans: Content of and Process for Submitting...