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Blog

Beware of Underestimating the Value of a Pre-NDA Meeting

By Lisa Crose | Blog, FDA | Comments are Closed | 19 November, 2020 | 0

Drug development is a resource-intensive endeavor. Seeking input from the U.S. Food and Drug Administration throughout the journey can help optimize those resources and maximize the likelihood of regulatory approval. When preparing to submit a new drug application (NDA), a pre-NDA meeting with the FDA can be a critical step in ensuring the submission ofRead more

Outsourcing-Pharma.com: Holistic Approach Benefits Drug Development

By Sameena Sharif | Blog | Comments are Closed | 12 October, 2020 | 1

Professionals focused on drug development are charged with making the most of their resources, maximizing the value of their work, and bringing effective products to market as quickly as they can without compromising quality or safety. It is a long list of responsibilities, and development professionals struggle to balance all of them. Sameena Sharif, seniorRead more

5 Tips to Avoid an IND Clinical Hold: Regulatory Guidance and Insights

By Aurora Sosa | Blog, Regulatory Affairs | Comments are Closed | 12 October, 2020 | 0

A clinical hold from the U.S. Food and Drug Administration can significantly prolong the time and increase the cost of drug development, which is particularly concerning for emerging/small biotech and specialty pharma companies. In this blog, we discuss common reasons for clinical holds and provide useful tips for both avoiding and addressing them. Brief backgroundRead more

The FDA Is Ending Its Rare Pediatric Disease Priority Review Vouchers – and Time Is Running Out to Get One

By Irene Figari | Blog, Regulatory Affairs | Comments are Closed | 31 July, 2020 | 1

Between 2010 and 2018, 33.8 percent of the 402 orphan indications approved by the FDA were approved for children only or targeted pediatric diseases.[1] The rare pediatric disease priority review voucher program is one incentive that’s helped to spur research and development in this area with more than 20 vouchers granted to date, but itRead more

Creating a Compliant eCTD: Avoiding Common Regulatory and Technical Pitfalls on the Path to Submission

By Valerie Bright | Blog, Regulatory Affairs | Comments are Closed | 23 July, 2020 | 6

The Electronic Common Technical Document (eCTD) is the standard format for submitting applications, amendments, supplements, and reports to the U.S. Food & Drug Administration (FDA). The eCTD harmonizes the regulatory review process for global drug development, as its structure is based on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human UseRead more

COVID-19 Update: How the FDA’s Emergency Use Authorization Can Help Develop Therapies Faster

By Nach Davé | Blog, COVID-19, Podcast | Comments are Closed | 8 April, 2020 | 0

As we continue to face the ongoing COVID-19 health emergency, the medical community is tasked with bringing solutions to patients in an expedited and safe manner. One such opportunity is to partner with the US FDA by submitting an Emergency Use Authorization (EUA) for any products that could immediately and effectively address a health emergency.Read more

COVID-19 & Clinical Trials: Direct-to-Patient Model Keeps Research Moving and Patients Safe

By Andrea Ochoa | Blog, COVID-19 | Comments are Closed | 7 April, 2020 | 0

In an effort to maintain the continuity of our clinical trials during the COVID-19 pandemic, Premier Research is helping customers take steps to safeguard the well-being of patients who were previously expected to go to a medical facility to receive treatment. A Direct-to-Patient (DTP) model applies only to studies for which the sponsor has hadRead more

COVID-19 Update: What Sponsors Need to Know About the New FDA Guidance

By Nach Davé | Blog, COVID-19, Podcast | Comments are Closed | 7 April, 2020 | 0

With the emergence of the COVID-19 pandemic, we are all experiencing uncertainty. This uncertainty is impacting our personal lives, and it’s also impacting and reshaping the critical research biotech and specialty pharma companies are conducting. In the first of a special new podcast series, hear from Nach Dave, Premier Research’s Vice President of Development Strategy,Read more

Statistical Considerations for FDA COVID-19 Guidance

By Shari Medendorp | Blog, COVID-19, FDA, Regulatory Affairs | Comments are Closed | 27 March, 2020 | 0

In response to the newly released U.S. Food and Drug Administration (FDA) guidance on COVID-19, the Statistics Department at Premier Research has committed to highlight specific and necessary actionable considerations that directly address key FDA recommendations in the guidance. These considerations call attention to some general actions required to ensure the operational integrity and scientificRead more

Snapshot: A New Guidance Document Program From the FDA

By Nach Davé | Blog, FDA, Regulatory Affairs | Comments are Closed | 27 March, 2020 | 0

As a regulatory affairs professional advising various stakeholders on the interpretation and implementation of guidance documents from the FDA, I can safely say that the task is challenging in the best of cases. FDA guidance documents have a tendency to be vague and difficult to decode. As experts, we are always debating about what theRead more

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Recent Posts

  • Beware of Underestimating the Value of a Pre-NDA Meeting
  • Outsourcing-Pharma.com: Holistic Approach Benefits Drug Development
  • 5 Tips to Avoid an IND Clinical Hold: Regulatory Guidance and Insights
  • The FDA Is Ending Its Rare Pediatric Disease Priority Review Vouchers – and Time Is Running Out to Get One
  • Creating a Compliant eCTD: Avoiding Common Regulatory and Technical Pitfalls on the Path to Submission

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  • About Us
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