FDA – Page 11 – DSI InPharmatics

U S Food and Drug Administration

April 1, 2021

Published by Meranda Parascandola at April 1, 2021

Establishing Regulatory Starting Materials & Understanding the ICH

There are many ways for companies to get approvals for expedited development. This is primarily based on trials and data from clinical studies. The biggest issue has always been how acceleration impacts CMC. In many cases, the data and the programs need time and cannot be expedited. So how do you ensure CMC doesn't become the bottleneck?

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.

April 6, 2022

Published by Meranda Parascandola at April 6, 2022

Nitrosamine Assessment

The FDA has been investigating the presence of nitrosamine impurities in certain drug products. Since 2018, several drug products including ARBs, ranitidine, nizatidine, and metformin have been found to contain unacceptable levels of nitrosamines. Nitrosamines are classified as probable human carcinogens based on animal studies and there has been a pressing need to remove the risk to patients.

June 7, 2022

Published by Meranda Parascandola at June 7, 2022

FDA-Required Medical Device Regulations

Medical devices have been saving lives for decades. And medical devices are quickly changing as new technology such as 3D printing, software, hardware and algorithms are being incorporated into device designs. Medical devices are not simply band aids and thermometers any longer. They are sophisticated designs that help people with a myriad of problems and in many cases, they prolong and save lives.

August 3, 2022

Published by Meranda Parascandola at August 3, 2022

Understanding the Relationship Between CMC & GMP

CMC information reinforces the connection between the quality of a candidate drug used in clinical studies and the end product marketed to consumers. It effectively outlines critical quality attributes across the full life cycle of drug products, from clinical development to commercial scale production. Like current good manufacturing practices (cGMP, or GMP), CMC reviews have regulatory requirements established by the US FDA. But where the goals of these two pharmaceutical control strategies are closely aligned, they differ significantly in approach and regulation.

January 6, 2023

Published by Meranda Parascandola at January 6, 2023

Your Company’s FDA Meeting Survival Guide

Product development is mainly a sequence of activities. Moving forward to the next step depends upon the result of the previous step. A regulatory deficiency in an early stage will therefore carry forward into all later stages. Fundamental CMC deficiencies at an early stage may require complete subsequent product redevelopment.