ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.
September 15, 2021
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...
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...
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...
March 26, 2018
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...
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...
November 6, 2017
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...
