thought leadership

ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.

FDA Modernization of Cosmetics Regulation Act (MoCRA)

March 9, 2023

MoCRA 2022: Updated Requirements for Cosmetic Companies

MoCRA enacts the most significant expansion of the US FDA to regulate cosmetics since 1938. After 85 years of effectiveness the Modernization of Cosmetics Regulation Act of 2022 or "MoCRA" was...

FDA Rare Diseases

March 1, 2023

Challenges in Clinical Development of Products for Rare Disease

Rare diseases are defined in the Orphan Drug Act as diseases or conditions that affect less than 200,000 people in the United States. There are over 7,000 rare diseases affecting more than 30 million...

Rare Diseases Orphan Drug Act

February 28, 2023

Rare/Orphan Diseases and the African American Community

How do we improve outcomes for an uncommon healthcare challenge in a community challenged with common healthcare issues?   The Orphan Drug Act defines a rare disease as a disease or condition that...

ATMP

February 20, 2023

The Boston ATMP Biotech Conquest

After panning over the Boston Business Journal and seeing yet another local VC (Venture Capital) firm raise a record $350 million in venture capital for Massachusetts life science, I asked myself:...

Life Science Consulting

December 6, 2022

Changes to the Animal Welfare Act Affecting Animal Research Facilities

Does your organization conduct or outsource testing to an Animal Research Facility?  If so, are you aware of the changes that have been implemented to the AWA (Animal Welfare Act) by the Animal and...

Regulatory Sciences

November 2, 2022

Ban on Titanium Dioxide (E171) on the EU Food Market: What Are the Consequences for Medicines?

Use of Titanium Dioxide in the EU Food Market In 2021, the European Food Safety Authority (EFSA) investigated the safety of the white coloring agent titanium dioxide (TiO2) and concluded that the...

Life Science Consulting

November 1, 2022

Be Careful What You Ask For (Prior to Consent)

According to FDA’s clinical trial regulations (21 CFR 50.20, 312.60 and 812.100), clinical investigators are responsible for protecting the rights, safety, and welfare of subjects during a clinical...

Life Science Consulting

October 28, 2022

ProPharma Group's Dr David Crome to Act as Compliance Monitor to the MHRA

From April 2022, the MHRA has been developing a pilot programme for GMP and GDP remediation supervision by eligible consultants acting as Compliance Monitors (CM) on behalf of companies that have...

Life Science Consulting

October 26, 2022

Your Vendor Audit Program: On-site or Remote / Virtual?

It is quite common that a sponsor company will outsource services to external vendors, whether for additional expertise, remote locations, or simply due to lack of availability of resources within...

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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Inspiring the Future of Drug Development

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