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Maximizing the Value of FDA Pre-IND Meetings for Successful 505(b)(2) NDA Submissions

For drug developers leveraging the 505(b)(2) pathway, the FDA Pre-Investigational New Drug (Pre-IND) meeting is a strategic opportunity that can shape the trajectory of an entire development program. These early interactions help Sponsors validate regulatory assumptions, align on data requirements,...

Various graphs and charts explaining Bayesian Emax Models

Clinical Research Solutions

FDA Designates Empirically Based Bayesian Emax Models for Dose Finding as ‘Fit-For-Purpose’

FDA Designates Empirically Based Bayesian Emax Models for Dose Finding as ‘Fit-For-Purpose’: On August 5, 2022, the U.S. Food and Drug Administration (FDA) designated ‘Empirically Based Bayesian Emax...

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Clinical Research Solutions

FDA Issues FY2021 Report on the State of Pharmaceutical Quality

FDA Issues FY2021 Report on the State of Pharmaceutical Quality: The Office of Pharmaceutical Quality (OPQ) within FDA’s Center for Drug Evaluation and Research has published the fiscal year 2021...

Clinical Research Solutions

FDA Publishes Responses to Good Clinical Practice Inquiries

FDA Publishes Responses to Good Clinical Practice Inquiries: FDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and FDA’s regulations....

Clinical Research Solutions

Orphan Designation of ATMPs for Rare Diseases: MPS II Case Study

Orphan Designation of ATMPs for Rare Diseases: MPS II Case Study Many advanced therapy medicinal products (ATMPs) in development in the EU are for rare diseases and conditions. Since the...

Clinical Research Solutions

EMA’s Emergency Task Force advises on intradermal use of Imvanex / Jynneos against monkeypox

August 19, 2022 EMA’s Emergency Task Force (ETF) has reviewed data on the monkeypox vaccine Imvanex 1 used as an intradermal injection (given just below the top layer of the skin). The vaccine is...

Clinical Research Solutions

FDA Pathways to Medical Device Approval

Commercializing your medical device in the US market often requires submitting a marketing application to the FDA to become an FDA Approved or Cleared Medical Device. The content of your FDA...

Clinical Research Solutions

FDA Solicits Feedback on ANDA Submissions – Amendments to ANDAs Under GDUFA Guidance, Appendix A

Ahead of this year’s reauthorization of the Generic Drug User Fee Amendments (GDUFA) , FDA has established a docket to solicit comments on the content of Appendix A in the July 2018 guidance for...

Clinical Research Solutions

EMA COVID-19 guidance: research and development

The European Medicines Agency (EMA) provides support to medicine developers researching and developing potential COVID-19 medicines. Dedicated guidance, rapid procedures and contact points are...

Clinical Research Solutions

From Idea to Market: The Five Stages of Product Development

The exact product development process for medical devices differs from region to region, with different regulatory expectations that need to be met in the EU, USA, UK and other regions. These precise...

Regulatory Sciences

What to Expect During the NDA Review Process

Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...

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Clinical Research Solutions

FDA’s Expedited Programs Explained

In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...

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Medical Information

What are Patient Support Programs?

Patient Support Programs (PSPs)  in the pharmaceutical sector offer a range of services to help patients start and adhere to their therapies, including Patient Assistance Programs (PAPs), patient...

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Regulatory Sciences

Formal FDA Meetings for Sponsors or Applications of PDUFA Products

This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...

Clinical Research Solutions

A Guide to the Clinical Study Report

What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...

Clinical Research Solutions

Understanding Statistical Intervals: Part 2 - Prediction Intervals

Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...

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