PDA PAC iAM 2017 Survey on Post Approval Change: Is the Regulatory Environment Hindering Much-Needed Innovation in the Pharma Industry?

PDA J Pharm Sci Technol. 2017 Sep-Oct;71(5):421-427. doi: 10.5731/pdajpst.2017.008219. Epub 2017 Aug 17.

Authors

Authors: Members of the PDA Task Force Post Approval Changes for Innovation in Availability of Medicines (PAC iAM); Emma Ramnarine¹, Ursula Busse², Marcello Colao³, Julia Edwards⁴, Kara Follman⁵, Karolyn Gale⁶, Kassidy Good⁷, Suzanne Kiani⁷, Maik Jornitz⁸, Morten Munk⁹, Kevin O'Donnel¹⁰, Melissa Seymour¹¹, Mihaela Simianu¹², Lisa Skeens⁵, Anders Vinther¹³, Denyse Baker¹⁴, Rich Levy¹⁴

Affiliations

¹ Genentech.
² Novartis.
³ GlaxoSmithKline Biologicals.
⁴ Allergan.
⁵ Pfizer.
⁶ Emergent BioSolutions.
⁷ Mylan Laboratories.
⁸ G-Con Manufacturing Inc.
⁹ NNE Pharmaplan.
¹⁰ HPRA.
¹¹ Biogen Melissa.seymour@biogen.com.
¹² Pharmatech.
¹³ Sanofi-Pasteur.
¹⁴ PDA.

PMID: 28819050
DOI: 10.5731/pdajpst.2017.008219

No abstract available

MeSH terms

Drug Approval / legislation & jurisprudence*
Drug Industry / legislation & jurisprudence
Drug Industry / organization & administration*
Humans
Organizational Innovation*
Surveys and Questionnaires