Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid.
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| Title: | Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid. |
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| Authors: | Algorri M; Amgen Inc., Thousand Oaks, CA USA., Acharya A; Merck & Co., Inc., Kenilworth, NJ USA., Bernstein J; Live Oak Pharmaceutical Consulting, Inc., Raleigh, NC USA., Cauchon NS; Amgen Inc., Thousand Oaks, CA USA., Chen XH; U.S. Food and Drug Administration, Office of Pharmaceutical Quality - Office of New Drug Products, Silver Spring, MD USA., Huynh-Ba K; Pharmalytik, LLC, Newark, DE USA., Krantz C; Seagen, Inc., Bothell, WA USA., Li T; Seagen, Inc., Bothell, WA USA., Li Y; U.S. Food and Drug Administration, Office of Pharmaceutical Quality - Office of Pharmaceutical Manufacturing Assessment, Silver Spring, MD USA., McLamore S; U.S. Food and Drug Administration, Office of Pharmaceutical Quality - Office of New Drug Products, Silver Spring, MD USA., Roberts SW; Novo Nordisk A/S, Vandtårnsvej 114, DK-2860 Søborg, Denmark., Schwinke D; AbbVie, North Chicago, IL USA., Shah R; U.S. Food and Drug Administration, Office of Pharmaceutical Quality - Office of Pharmaceutical Manufacturing Assessment, Silver Spring, MD USA., Schirmer A; Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT USA., Strickland H; GlaxoSmithKline US, Research Triangle Park, NC USA., Tang K; Genentech, Inc., South San Francisco, CA USA., Watson T; Pfizer Inc., Groton, CT USA. |
| Source: | AAPS open [AAPS Open] 2022; Vol. 8 (1), pp. 19. Date of Electronic Publication: 2022 Dec 05. |
| Publication Type: | Journal Article |
| Journal Info: | Publisher: SpringerOpen Country of Publication: England NLM ID: 101742151 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2364-9534 (Electronic) Linking ISSN: 23649534 NLM ISO Abbreviation: AAPS Open Subsets: PubMed not MEDLINE |
| Database: | MEDLINE Ultimate |
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| ISSN: | 2364-9534 |
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| DOI: | 10.1186/s41120-022-00066-1 |
