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FDA Programs to Support Advanced Manufacturing: Where Innovation Meets Regulation

The Premier Consulting Blog

It is recognized, however, that there is a learning curve across the industry and FDA that is inherent to the development of such novel technologies. To prevent this learning curve from becoming a roadblock on the path to regulatory approval, the FDA has developed several collaborative programs to support advanced manufacturing.

FDA
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FDA Inspections: Lesson 1 – Interviewing Employees

FDA Law Blog: Biosimilars

Farquhar This is the first in a series of blog posts on tips for successfully handling an FDA inspection. Using publicly available examples, these lessons will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection. FD&C Act 501(j).

FDA
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Time for change: non-human primates in drug research

Drug Target Review

But growing ethical scrutiny, supply shortages, cost burdens, scientific innovation and regulatory shifts like the US Food and Drug Administration (FDA)’s new alternative methods roadmap are bringing the continued reliance on live NHPs into question, and opening the door to next-generation solutions that could eventually replace them altogether.

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FDA Approves Merck’s ENFLONSIA™ to Prevent RSV in Infants

The Pharma Data

FDA Approves Merck’s ENFLONSIA™ to Protect Infants from Severe RSV Illness Merck operating as MSD outside the United States and Canada, has received a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) granting approval for ENFLONSIA™ (clesrovimab-cfor). A New Era in Infant RSV Protection Dr. Dean Y.

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Prime editing treats childhood brain disease in mice

Broad Institute

& Researchers at the Broad Institute and The Jackson Laboratory have used prime editing, a precise and versatile form of gene editing, to correct the root cause of AHC in mice. There is no cure or effective treatment for this rare genetic disease, but new research suggests a potential path to one.&

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Bio-Techne Joins Forces with USP to Speed Up Development of mAbs and Gene Therapies

The Pharma Data

These standards are widely recognized by regulatory agencies such as the FDA and EMA for use in analytical method development, validation, and quality control.

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The Role of Big Data in Clinical Trials

Quanticate

Clinical research generates vast amounts of diverse data from laboratory tests, patients, medical equipment, and outside sources. By organising and analysing this information, researchers can extract actionable insights that improve patient outcomes, data accuracy, drug efficacy and speed up trials.