Quality & Compliance
Life Science Consulting
September 15, 2021
You Just Received a 483, Now What?
Remember the last time you were pulled over by the police? Maybe you had a taillight out. Perhaps you were speeding. You may have believed that you had done nothing wrong. Regardless of the specific...
Quality & Compliance
GMP
June 6, 2019
Why the FDA Should Never Be Your First Inspection
You can expect several FDA audits throughout your drug development program The Agency’s goal is to protect the public from unsafe products, and one of the best ways to accomplish that goal is by...
Quality & Compliance
GMP
December 4, 2018
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...
Quality & Compliance
Good Clinical Practice
October 22, 2018
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...
Quality & Compliance
Good Clinical Practice
October 18, 2018
Pros and Cons of Working with a CRO
Sponsors may transfer any or all of their many tasks and obligations relating to clinical trials to Contract Research Organizations (CROs). This ability to delegate through a Transfer of Regulatory...
Quality & Compliance
GMP
July 23, 2018
FDA Announces Voluntary Recall of Drugs Containing Valsartan
On Friday, July 13th, FDA announced the voluntary recall of several drugs containing the active ingredient valsartan. Valsartan is often used to treat serious medical conditions such as high blood...
Quality & Compliance
Agency Alerts
March 26, 2018
First Clinical Study Report Data Published for FDA Pilot Project
On Monday, March 19th, the FDA officially began a new Clinical Data Summary Pilot Program. This program is intended to “assess the feasibility of using a different format to provide required...
Medical Device
Quality & Compliance
February 22, 2018
FDA’s Final Rule Sets GCP Standards for Medical Device Trials Conducted Outside US
On Wednesday, February 21st, the FDA released a final rule entitled “Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices.” The new rule amends the Agency’s...
Quality & Compliance
GMP
November 6, 2017
FDA Takes Steps to Improve Efficiency of Global Pharmaceutical Manufacturing Inspections
On Tuesday, October 31st, the FDA announced that it will begin allowing eight European drug regulatory authorities to conduct inspections of manufacturing facilities and determine whether or not they...