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FDA Sterile Compounding

September 29, 2017

Using a Matrix Approach to Media Fills in Sterile Compounding

Using a Matrix Approach to Media Fills in Sterile Compounding: A survey of FDA Form 483 observations issued to the 503B pharmacy industry reveals that outsourcing compounders are struggling to...

Life Science Consulting Compounding Pharmacy

April 5, 2016

The 503b Outsourcing Facility Compliance Dilemma

At the time of this writing, there were 59 registered 503b outsourcing facilities posted on the FDA’s website. All firms that had been inspected were issued FDA inspectional observations in the form...

Life Science Consulting Compounding Pharmacy

December 4, 2014

Outsourcing Facilities and GMP: The Quality Systems Challenge

Compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcingfacility, a person under the supervision of a licensed pharmacist, combines, mixes, or...

Life Science Consulting Compounding Pharmacy

July 16, 2014

Outsourcing Facilities and GMP: The Validation Challenge

Compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes,...

Life Science Consulting Compounding Pharmacy

May 14, 2014

Outsourcing Facilities and GMP: A New Relationship

Compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes,...

Life Science Consulting Compounding Pharmacy

December 19, 2013

What is the Future for Pharmaceutical Compounding Companies?

The Food and Drug Administration (FDA) may soon be cracking down on compounding pharmacies according to a recent bill introduced in the United States Legislature.  The bill (Drug Quality and Security...

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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