There are many pitfalls that come with preparing an Investigational New Drug application for FDA submission. Luckily, there are also plenty of ways to avoid them. But the most important strategy? It all comes down to one thing: Always remember to keep your audience (the FDA reviewers) in mind as you write. These five actionable...
DURHAM, N.C., August 7, 2017 — Premier Research announces the appointment of Nach Davé, RPh, MS, as Vice President of Global Regulatory Affairs. He oversees the company’s regulatory affairs service offerings in rare diseases and across its broad range of therapeutic focus areas, bringing to the position more than 20 years of experience in the...
The study of rare cancers poses special challenges for drug developers, who often must draw on their experience in both oncology and rare disease. Careful consideration of clinical trial design and regulatory pathways can help increase the likelihood of success in rare oncology clinical trials. Researchers studying rare cancers must call on expertise in both...
Proper preparation of an Investigational New Drug (IND) application is a carefully orchestrated process that requires many disciplines to collaborate in delivering a consistent message regarding the safety of an investigative compound. Proactively identifying and avoiding common IND submission pitfalls can help ensure that your application is clear, concise, and error-free. Preparation of an Investigational...
Neurodegenerative disorders present some of the biggest challenges in planning and conducting clinical drug trials. Identifying strategies to proactively address or mitigate these challenges can help to ensure a successful trial. Since the first drugs for neurodegenerative diseases (NDDs) were approved in the 1990s, an increasing number of disease- modifying therapies have been approved for...
In December 2016, the United States passed an important piece of regulatory legislation called the 21st Century Cures Act. These FDA regulations cover multiple types of clinical research but include some specific provisions for medical device development. In contrast to the regulatory reform seen in the EU — which includes a much-needed increased emphasis on...
Good clinical practice (GCP) guidelines govern important aspects of clinical trials to ensure patient safety and scientific integrity. “GCP” is a quality standard which refers to the document put forth by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH is a group made up of regulatory officials...
No matter your role in the industry, you may have heard about the significant upcoming changes to European medical device regulations. But just what are they? What’s the proposed implementation timeline? Here’s an overview of the proposed legislation, as well as a tentative schedule of important dates. Getting Up to Speed In June 2016, the...
With increasing demands for evidence of clinical efficacy and safety, applying sound research practices to medical device development is crucial for a product’s success. The Need for High Standards in Study Design When bringing a new medical device to the market — or even reevaluating an existing product — device companies must answer to: Regulators placing greater scrutiny on...
Pain is a significant health problem that impacts quality of life and imparts high costs to society. Despite intense research effort and progress in our understanding of the mechanistic and molecular basis of pain, there have been few real breakthroughs in novel analgesic drug development over the past 50 years. One major obstacle to the...