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New Resource for Regulatory Professionals Preparing for FDA Inspections
The FDA continues to increase its focus and attention on ensuring the safety of the drug supply in the U.S. Manufacturing facilities are regularly inspected by the FDA for cGMP, or current good manufacturing practices. With an increasingly complex supply chain - more and more drugs consumed by Americans are manufactured abroad, this has grown into a global effort. In 2014, the FDA conducted a record number of inspections internationally, and many experts believe 2015 will only continue in that thread.
With quickly changing regulations and new guidance appearing almost on a daily basis, and with international bodies attempting to coordinate efforts and standards, biopharma professionals spend an inordinate amount of time sifting a mountain of technical information to try to stay updated on the latest developments. Sometimes, companies can't keep up with the latest version of guidance, and on ocassion, will be written up by the FDA via a FDA report called the Form 483.
To address this problem, FDAzilla has launched a new newsletter, GMP Regulatory Intelligence. The only weekly newsletter of its kind, this new resource provides a quick run-down of new laws, regulations, guidance, and concept papers published or posted that week- not just for the FDA, but also EMA, PIC/S, and ICH.
One GMP Consultant noted, ‘I have been working with many companies who do not have an intelligence officer and feel blind-sided by things that they otherwise would have been prepared for had they had the necessary intelligence of ‘current’ events. In today’s information overload, a newsletter like this will greatly help companies (of all sizes) achieve the “C” in the “cGMP.”’
A Manager of Regulatory Intelligence & Policy at a large pharmaceutical company noted, "Currently, I spend my days tracking this kind of news down. To find it all in one place is great."
Also included in the newsletter are updates on FDA warning letters, FDA drug recalls, FDA import alerts for drugs and selected devices, Eudra GMDP reports of non-compliance, and regulatory actions that published that week.
"Our goal is to help people work smarter with FDA data," said Tony Chen, CEO of FDAzilla. "We're excited to partner with subject matter expert, Barbara Unger, to offer this newsletter to the industry. Barbara's deep experience in this arena, sharpened by decades of experience, provides much-needed curation and context to the field of regulatory intelligence."
For more information about Barbara Unger or the newsletter, please visit: http://fdazilla.com/
Page Updated Last on: Jan 26, 2015