Zobrazeno 1 - 2
of 2
pro vyhledávání: '"Paula R Katz"'
Autor:
Mary Oates, Sau L. Lee, Tony Tong, Ganapathy Mohan, Giuseppe Randazzo, Michael P. Thien, Geoffrey K. Wu, Adam C. Fisher, Robert Ju, Richard T Lostritto, Emanuela Lacana, Bruce D. Johnson, Katherine M. Tyner, Stephen W. Hoag, Brian Hasselbalch, Grace McNally, Susan Rosencrance, Anna Schwendeman, Louis Yu, Moheb Nasr, Martin VanTrieste, Tara Gooen Bizjak, Henry A. Havel, Paul Seo, Siva Vaithiyalingam, Barbara Allen, Lawrence X. Yu, Ilgaz Akseli, Thomas F. O’Connor, Gregory E. Amidon, Ramesh Sood, Roger Nosal, Margaret Caulk, Ashley Boam, Janet Woodcock, Paula R Katz, Fionnuala Walsh, Robert Iser, Vinod P. Shah, Scott Furness, Larisa Wu, Russell Wesdyk, G. K. Raju, Joseph Famulare, Mahesh Ramanadham, Arzu Selen, Mehul Mehta, James E. Polli, David Doleski, Diane Zezza, Bernhardt L. Trout
Publikováno v:
The AAPS journal. 18(2)
The October 2015 FDA/PQRI Conference on Advancing Product Quality provided a forum for the exchange of ideas focused on drug product quality between regulatory agencies, the pharmaceutical industry, and academia. Key topics of the 2015 conference wer
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a4fa8e10c71dffd445e850573ee75ded
https://pubmed.ncbi.nlm.nih.gov/26860627
https://pubmed.ncbi.nlm.nih.gov/26860627
Autor:
Paula R, Katz
Publikováno v:
Food and drug law journal. 65(3)
FDA's recent use of the Application Integrity Policy (AIP), most notably in the ongoing Ranbaxy matter, has created interest in the policy. The article discusses actions CDER's Office of Compliance is currently undertaking to raise awareness of the A
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::db5f9aedef0ab6f38cacb755721071e5
https://pubmed.ncbi.nlm.nih.gov/24479240
https://pubmed.ncbi.nlm.nih.gov/24479240