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.
The Impact of a US Government Shutdown on the Food and Drug Administration
September 27, 2023
U.S. lawmakers are actively attempting to negotiate a deal to prevent a government shutdown on October 1, 2023. Along with many other government agencies, the ability of the Food and Drug...
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,...
On December 13, 2016, the 21st Century Cures Act was signed into law with the intention of speeding FDA’s approval time for drugs and medical devices. When signed, the Cures Act increased FDA’s...
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...
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...
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