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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...

FDA North America

August 26, 2022

FDA Announces Availability of Multiple Draft Guidances - Drug Information Update

Today, FDA announced the availability of the following draft guidances for industry, which were prepared under the support of the International Council for Harmonisation of Technical Requirements for...

FDA North America

August 25, 2022

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...

FDA North America

August 25, 2022

FDA - Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies

FDA - Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies. August 2022 This final guidance is intended to help applicants (or “you”) design and...

FDA North America

August 25, 2022

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...

FDA North America

August 22, 2022

FDA Issues Revised Draft Guidance on Charging for Investigational Drugs Under an Investigational New Drug Application

August 2022 Draft Guidance This guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA’s regulations on...

FDA North America

August 22, 2022

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....

FDA North America

August 17, 2022

Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions

Draft Guidance for Industry and Food and Drug Administration Staff AUGUST 2022 FDA is issuing this draft guidance to provide labeling recommendations for hydrogen peroxide-based contact lens care...

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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