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Data Integrity Guidance Adds Focus On Culture, Best Practices And APIs

 
• By Joanne S. Eglovitch

In response to comments, US FDA’s final guidance on data integrity further refines and expands on some of the principles and best practices espoused in the draft version to help pharmaceutical manufacturers counter a growing problem with inaccurate data. This problem continues to consume a good deal of FDA’s GMP enforcement efforts.

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FDA’s final guidance on data integrity stresses the importance of a strong quality culture and a lifecycle approach to data management to ward off potential threats of data manipulation.

The Dec. 12 guidance, called “Data Integrity and Compliance With Drug cGMP: Questions And Answers,” amends an April 2016...

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More from United States

Liver Injury REMS Delays US FDA Approval Of Agios’s Pyrukynd In Thalassemia

 
• By Mandy Jackson

Approval in alpha- and beta-thalassemia by the Sept. 7 action date seemed assured, but an FDA review of a proposed REMS for potential liver injury pushed the decision to Dec. 7.

Sticker Shock? Cost Of Orphan Drug Medicare Negotiation Relief May Complicate Future Fixes

 
• By Cathy Kelly

Heavy lobbying produced relief for orphan drugs in President Trump's budget reconciliation law and the cost of the changes to Medicare now is becoming clearer.

Complete Response Letters: Will Industry Fight US FDA’s Disclosure Plans?

 
• By Sue Sutter

The FDA's release of CRLs for unapproved products could bring a court challenge, but for now, sponsors should expect all past and future letters will be made public, experts said.

Pink Sheet Podcast: US FDA Drops Offit From Adcom, Releases Unapproved Product CRLs

 
• By Derrick Gingery, Bridget Silverman, Sue Sutter, and Nielsen Hobbs

Pink Sheet editors discuss the recent departure of a noted vaccine expert and many others from FDA advisory committee rosters, as well as the details and potential impact of the FDA’s release of dozens of complete response letters for unapproved products.

More from North America

89 Complete Response Letters For Unapproved Drugs, One Huge Leap For US FDA Transparency

 
• By Bridget Silverman

The US FDA’s unprecedented publication of 89 recent CRLs for unapproved products comes with a promise to release future letters more promptly.

Kennedy Maintains mRNA Negativity Even When Couched As Trump Success

 
• By Sarah Karlin-Smith

The Health and Human Services Secretary's Sept. 4 appearance at the Senate Finance Committee also revealed more Republicans are souring on his vaccine policies, although most still support him.

US FDA’s New ‘Plausible Mechanism Of Action’ Pathway Limited To Bespoke Therapies

 
• By Sue Sutter

Center for Biologics Evaluation and Research Director Vinay Prasad and Commissioner Martin Makary will introduce the new pathway soon in a New England Journal of Medicine article.