CMC – Page 6 – DSI InPharmatics

Chemistry, Manufacturing and Controls

December 3, 2020

Published by Meranda Parascandola at December 3, 2020

What It Means to Be “Breakthrough”: The Story Behind The FDA Designation

This bill expanded many of the existing governing powers of the FDA but also added one intriguing new provision: the breakthrough therapy (BT) designation, intended to expedite the development and review of drugs for serious or life-threatening conditions.

December 15, 2020

Published by Meranda Parascandola at December 15, 2020

Phase 1 Stability; Agency Expectations

Before you decide how much stability data you require, it is vital to understand the nature of your Dosage Form and Delivery System Requirements (the route of administration and delivery system). Even if there is a diversity of testing in place, these choices have a significant impact on the scientific and regulatory aspects of a stability protocol, which can still fail to meet the most stringent regulatory reviews.

January 21, 2021

Published by Meranda Parascandola at January 21, 2021

Understanding Regulatory Submissions and the Role of Regulatory CMC Project Management

What is regulatory CMC? An individual in a regulatory affairs CMC role provides the strategy and knowledge needed to ensure that CMC practices are carried out in accordance with the requirements of regulatory bodies, such as the FDA (US Food and Drug Administration) and EMA (European Medicines Agency). CMC regulatory is pivotal in ensuring that drugs and treatments being manufactured are safe, effective, and of high quality for patients.

February 4, 2021

Published by Meranda Parascandola at February 4, 2021

What the Super Bowl Can Teach Us about CMC Strategy

It all starts with a game plan. Just like any Super Bowl contender starts with a game plan, anyone involved with drug development should too. A CMC game plan becomes your pathway to success.

April 15, 2021

Published by Meranda Parascandola at April 15, 2021

Material Characterization and Formulation Development

Learn how to guide sponsors in the critical exercise of materials characterization and the establishment of reference standards for NCEs as well as in the formulation of drug products from the IND-enabling stages of development through postapproval evergreening changes.

June 3, 2021

Published by Meranda Parascandola at June 3, 2021

Meetings Between the FDA and Sponsors Aren’t Quite What You Think They Are

FDA Meetings aren’t what many people think they are especially when it comes to the CMC-focused discussions. We look at seven common opinions about formal meetings between the FDA and Sponsors or Applicants of PDUFA Products when it comes to CMC compliance and compare them to reality.