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Medical Device fda submission

July 12, 2021

Pedaling While Fixing a Flat: Conducting a Good FDA Meeting Under Bad Circumstances

Before using a significant risk medical device in a clinical study, Sponsors must first obtain FDA approval. Frequently, the request for an investigational device exemption (IDE) is disapproved, and...

Generic Drugs Agency Alerts

August 22, 2019

Only 12% of Generic Drugs Reviewed Were Approved in the 1st Review Cycle, says GAO Report

On August 7th, the U.S. Government Accountability Office (GAO) published its report on generic drug applications.  In the report, GAO comments on the number of products approved on the first review...

Medical Device Agency Alerts

February 12, 2019

FDA Issues Draft Guidance to Advance Development of Combination Products

On Tuesday, February 5th, FDA published a draft guidance explaining the principles for premarket review of combination products, including how to determine which type of premarket submission is...

Agency Alerts General Regulatory

January 21, 2019

FDA Draft Guidance on Tentatively Approved ANDA Submissions

FDA Draft Guidance on Tentatively Approved ANDA Submissions: On Wednesday, January 16th, the FDA published its first draft guidance since the partial government shutdown took effect on December 22,...

Agency Alerts General Regulatory

December 17, 2018

FDA Takes Big Steps to Advance its Biosimilar Policy Framework

On Tuesday, December 11th, FDA made large strides to advance its biosimilar policy framework, including the release of four guidance documents and a proposed rule.  Through these guidance documents,...

Agency Alerts General Regulatory

November 27, 2018

FDA Takes Steps to Promote Digital Tools for Prescription Drugs

On Tuesday, November 20th, FDA announced the establishment of a public docket to solicit comments and feedback on a proposed framework regarding the regulation of prescription drug-use-related...

Good Clinical Practice Agency Alerts

November 2, 2018

FDA Seeks Feedback on Surrogate Endpoint Table

On December 13, 2016, the 21st Century Cures Act was signed into law with the intention of speeding FDA’s approval time for drugs and medical devices.  When signed, the Cures Act increased FDA’s...

Generic Drugs Agency Alerts

October 1, 2018

FDA Issues Final Guidance Regarding Content & Format Requirements for ANDA Submissions

On Tuesday, September 25th, the FDA issued a guidance document entitled “ANDA Submissions – Content and Format.”  The document, initially issued as a draft guidance in June 2014, provides sponsors...

Agency Alerts General Regulatory

September 27, 2018

Good Review Management Principles & Practices, Part Two: Operational Principles

Details on the fundamental values outlined on FDA’s GRMP draft guidance are available in our preceding article, entitled “Good Review Management Principles & Practices, Part One: Fundamental Values"...

Statistical Intervals Confidence Interval Process Validation Life Science Consulting featured-image

Aug 15, 2013 12:00:00 AM

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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Mar 29, 2022 12:00:00 AM

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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Dec 22, 2020 12:00:00 AM

How Important is Biostatistics?

The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded...

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Dec 8, 2020 12:00:00 AM

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...

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Feb 28, 2017 12:00:00 AM

Formal Meetings Between the FDA & Sponsors or Applicants of PDUFA Products

On March 10, 2015, the FDA published a draft guidance, providing a number of recommendations regarding the conduct of formal meetings between the FDA and Sponsors. These meetings are intended to...

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Regulatory Sciences featured-image

Oct 12, 2022 12:00:00 AM

Prescription Drug User Fee Act (PDUFA) VII and Type D Meetings: A New Mechanism for Interacting with FDA

For those who have been awaiting Congressional reauthorization of PDUFA, the wait is over. On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022. We...

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