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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

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

Businesswoman using laptop in office

Why Did My NDA Become a BLA on March 23, 2020?

By Nach Davé | Blog, FDA, Regulatory Affairs | Comments are Closed | 25 March, 2020 | 0

During these challenging times when the world is focused on COVID-19 and the matters at hand, it’s understandable if you didn’t take much notice of March 23 as a significant date – one that’s been on the FDA’s radar for a while. March 23, 2020, was the date when certain New Drug Applications (NDAs) wereRead more

UPDATE – Draft FDA Guidance Concerning Combination Products

By Ann Leonard | Blog, FDA, Regulatory Affairs | Comments are Closed | 18 March, 2020 | 0

As those working in the development of combination products likely know, the Food and Drug Administration (FDA) issued two new draft guidances in December 2019. The guidances – Requesting FDA Feedback on Combination Products and Bridging for Drug-Device and Biologic-Device Combination Products – were published in response to the 21st Century Cures Act and PrescriptionRead more

FDA Releases Draft Guidance for Transdermal Product Development

By Lisa Crose | Blog, FDA | Comments are Closed | 12 March, 2020 | 4

Transdermal and topical delivery systems (TDS) are important dosage forms that allow delivery of a drug to local tissue or provide systemic delivery through the skin. These drug products provide a number of advantages for patients, but can be challenging to develop. In November 2019, the FDA issued a draft guidance entitled Transdermal and TopicalRead more

Streamline Early Clinical Development With an INTERACT Meeting

By Ann Leonard | Blog, FDA, INTERACT Meeting | Comments are Closed | 11 March, 2020 | 3

In October 2018, the Food and Drug Administration (FDA) issued Standard Operating Policy and Procedure (SOPP) – SOPP 8214 Version 1.0: INTERACT Meetings with Sponsors for Drugs and Biological Products. This document details recommendations for the Center for Biologics Evaluation and Research (CBER)’s engagement with sponsors (such as industry and investigators) in an early developmentRead more

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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