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General Regulatory Drug Approval

October 5, 2021

Four Benefits of Requesting an FDA Pre-IND Meeting

Although not required, a Pre-IND Meeting is a critical milestone, one that is highly recommended by the FDA. The goal of the meeting is to receive general agreement from FDA that your drug...

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...

Agency Alerts General Regulatory

November 1, 2018

FDA Encourages Development of Novel Drugs for Rare Diseases with Draft Guidance Regarding the Role of Pre-IND Meetings

On Monday, October 12th, FDA issued a draft guidance regarding the role of Pre-IND Meetings in the development of drugs to treat rare diseases. The document, entitled "Rare Diseases: Early Drug...

Agency Alerts General Regulatory

October 4, 2018

CBER Provides Sponsors with Policies & Procedures Regarding INTERACT Meetings

On Monday, October 1, FDA’s Center for Biologics Evaluation and Research (CBER) issued a document outlining the policies and procedures for scheduling and conducting INitial Targeted Engagement for...

General Regulatory Drug Approval

September 20, 2017

FDA Meetings: How to Prepare for FDA Type B Meetings

The Food and Drug Administration has laid out a drug development continuum that includes three milestones, or Type B meetings. Earliest is the Pre-IND Meeting, the second is the End of Phase 2 (EOP2)...

Agency Alerts General Regulatory

June 16, 2017

FDA to Host Public Workshop to Discuss the Impact of Abuse Deterrent Opioids

On Wednesday, June 14th, the FDA announced plans to host a public workshop regarding the impact of opioid formulations with abuse deterrent properties.  The workshop, entitled “Data and Methods for...

Agency Alerts General Regulatory

March 7, 2017

FDA to Hold Public Meeting to Discuss Patient-Focused Drug Development for Autism

On Monday, March 6th, the FDA announced plans to hold a public meeting regarding the development of patient-focused drugs for autism.  In the notice published in the Federal Register, the FDA notes...

General Regulatory FDA Meetings

February 28, 2017

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...

General Regulatory FDA Meetings

November 9, 2016

#8: Special Protocol Assessment

The Food and Drug Administration (FDA) released a draft guidance on the Special Protocol Assessment (SPA) in May 2016, updating the original SPA guidance issued in 2002. SPAs are meant to give...

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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General Regulatory Drug Approval Regulatory Sciences featured-image

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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Biostatistics Clinical Research Solutions featured-image

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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ICH MW QC CSR Clinical Research Solutions featured-image

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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General Regulatory FDA Meetings Regulatory Sciences featured-image

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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