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July 13, 2022
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...
June 6, 2019
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...
December 4, 2018
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...
November 16, 2018
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,...
October 22, 2018
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...
October 18, 2018
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...
July 23, 2018
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...
February 22, 2018
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...
June 28, 2017
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...