Preparing for the New Era of Hybrid Regulatory Inspections

The FDA has strengthened its use of remote inspection and integrate desk-based assessments with traditional on-site visits. This outlines what you need to know about this new era of hybrid inspections

New FDA Guidance Addresses the Need for Data-Generation Strategies Across the Drug Development Lifecycle

David Brown, Global Head of Epidemiology, summarizes the three FDA guidances related to data sources, data standards, and regulatory considerations in RWE/RWD and benefits of early engagement.

Four reasons to conduct robust natural history studies before clinical trials

Lucas Kempf, former regulator, reflects on his time at the FDA and outlines why companies should invest in a high-quality natural history study.

Breaking through complex regulations and science speak – thinking “patients first” in lay language summary development

In this blog, our experts explore how to develop multi-purpose, patient-centric lay language summaries with the patient audience firmly in mind.

We need faster endpoints for targeted cancer drugs, and there is one

As a former regulator, Jorge shares his perspectives for the need of more faster endpoints to measure how targeted cancer drugs can benefit patients. He believes it can be created by combining two...

Three ways to improve your chances that insurers will pay for a new CGT

When developing cell and gene therapies (CGTs), drug companies face significant hurdles. One of which is getting insurance companies to pay for these treatments that can potentially cure patients...

The Parexel Podcast | Episode 15: Pandemic preparedness: Investing in the future of infectious disease vaccine development

How market exclusivities can affect your development program

Drug Development for Rare Disease and Oncology During the COVID-19 Pandemic

Hong Kong Exchange: Nurturing China’s Biotech Valley

About the Authors Daniel Huang is an Analyst based in the Hong Kong...

The Move Toward Global Standards: Navigating New EAEU Guidelines

As the pandemic clearly revealed, there is an urgent need for a more cohesive, coordinated approach to streamline global regulatory guidelines to ensure patients have faster access to new and...

The Special Approval Pathway (SAP) for COVID-19 related products in China

The regulatory pathway for COVID-19 drugs in China is governed by the Special Approval Program (SAP) which was introduced by National Medical Product Administration (NMPA) in 2005.  SAP is...

NMPA Guidance on the Management of Clinical Trials during the COVID-19 from July 2020

Conducting clinical trials during the COVID-19 pandemic has produced many challenges globally. The initiation, conduct, implementation and completion of a trial during this time requires special...

Top 10 Myths About Working with the FDA for an Oncology Drug Approval

Among biotech companies, a primary concern is how to establish a clinical strategy for scientific and commercial success at the earliest stage. In that respect, regulatory considerations figure...

GxP On-Site Inspections are Restarting: Preparing for inspections under the “new normal”

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...

Making a Seamless Transition to Virtual Meetings with Health Authorities: Best Practices and Recommendations

Chances are, you are reading this article in your home office, or perhaps in a corner of the dining room – but probably not in your normal workspace. Just as most of us have had to adjust to...

FDA Expectations for Responding to Employees in Pharmaceutical Manufacturing Infected with COVID-19

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...

Using risk assessment decision tree models to maintain safety and data validity in clinical trials during COVID-19

During the COVID-19 pandemic, challenges to the conduct of clinical trials may arise, e.g. due to travel restrictions or quarantines, interruptions to supply chains, or when site personnel or...

Putting the Pandemic in Plain Language

The COVID-19 pandemic has brought many negative feelings to the forefront of our everyday lives, including anxiety, fear and social division, but what if we explored the new positive relationships...

SARS-CoV-2 Landscape of Repurposed Drug Trials and Key Lessons for the Future

About the Authors Saakshi Chadha, PhD is a Senior Analyst in the Health...