EMA
Europe
July 13, 2022
EMA Good clinical practice (GCP) inspection procedures
The Good Clinical Practice (GCP) Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections requested by the European Medicines...
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...
Good Clinical Practice
Agency Alerts
November 16, 2018
FDA to Modify Informed Consent Rules, Seeks Feedback
On Tuesday, November 13th, FDA proposed to add an exception to its informed consent requirements for minimal risk FDA-regulated clinical investigations. Under the Agency’s current regulations,...
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...
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
June 28, 2017
Sterility Concerns Cause Voluntary Recall of Various Products: Potassium Phosphate & Succinylchoine Chloride
On June 15, 2017, Hospira Inc. issued a voluntary recall of a number of its products after finding a microbial growth during a routine simulation of the manufacturing process, which represents the...