Parexel Regulatory & Access Hub
Welcome to the Parexel Regulatory & Access Hub
2:08Parexel regulatory expert, Mark Birse, gives an update on BREXIT.
As global regulatory agencies are preparing to return to on-site inspections1, industry needs to be ready. With the continued threat of COVID-19, the way inspections will be performed and hosted...
Global manufacturers and regulators are facing new challenges during the SARS-CoV-2 pandemic to maintain supply chains, and avoid shortages, of drugs, biologics and medical devices. Numerous...
Introduction The recent COVID-19 pandemic has triggered a race for pharmaceutical companies to repurpose their commercialized drugs approved for other clinical indications to treat patients...
This assessment highlights some planning considerations to help you maintain business operations, while protecting the safety of employees and customers during this pandemic.
A diagram that shows various procedural steps when interacting with the FDA through CTAP.
At the recent 2019 Enforcement, Litigation and Compliance Conference hosted by the Food and Drug Law Institute (see here), Deputy Assistant Attorney General David Morrell delivered the...
The Office of Compliance (OC) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) is a large organization. It has hundreds of personnel who are...
If the dictionary is to be believed, the expression that kings have long arms was first listed as a proverb in 1539 (see here). Over time it has developed into the commonly recognized idea...
Over the last few years the expansion of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) has continued at pace, with more Good Manufacturing Practice (GMP) Inspectorates joining,...
In a prior blog post, I wrote about the issue of whether corporate boards of directors could be confronted with the issue of whether they could be held liable for not implementing a...
In January 2020 the Food and Drug Administration (FDA or “agency”) published the revised draft guidance Current Good Manufacturing Practice – Guidance for Human Drug Compounding Outsourcing...
