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Drug Regulation

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...

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Microfluidic-based Synthesis of Covalent Organic Frameworks COFs: A Tool for Continuous Production of COF Fibers and Direct Printing on a Surface

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FDA/M-CERSI Co-Processed API Workshop Proceedings.

Luke Schenck¹, Paresma Patel², Ramesh Sood²

¹Process Research & Development, Merck & Co., Inc., Rahway, New Jersey 07065, United States.

Journal of Pharmaceutical Sciences

|January 13, 2023

Summary

This summary is machine-generated.

Co-processed active pharmaceutical ingredients (APIs) offer advancements in drug substance properties and manufacturing. This workshop explored regulatory pathways for co-processed APIs from development to commercialization.

Keywords:

Co-processed API Co-processing Particle engineering Regulatory

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Area of Science:

Pharmaceutical Sciences
Drug Development
Regulatory Science

Background:

Co-processed active pharmaceutical ingredients (APIs) represent a novel technology.
This technology aims to enhance drug substance physicochemical properties.
It also seeks to improve drug product manufacturing process robustness.

Purpose of the Study:

To summarize discussions from the M-CERSI Workshop on Co-processed API.
To examine advances in co-processed API technology.
To explore regulatory considerations for commercialization.

Main Methods:

Workshop presentations from industry, academia, and the FDA.
Breakout sessions for facilitated stakeholder discussions.
Compilation of presentation summaries and discussion highlights.

Main Results:

Recent advances in co-processed API technology were presented.
Regulatory aspects including classification, CMC strategies, and documentation were discussed.
Proposals for enabling commercialization of co-processed APIs were explored.

Conclusions:

Co-processed APIs present a transformative approach to drug development.
Further visibility into discussions and perspectives on co-processed APIs is needed.
Regulatory pathways require careful consideration for successful commercialization.