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Therapeutic Innovation & Regulatory Science|September 19, 2018
Trans-Pacific Partnership Agreement and Its Impact on Accessibility and Affordability of Medicines: A Meta-synthesisYan Yee Yap, Che Pui Wong, Kah Seng Lee, et al.Therapeutic Innovation & Regulatory Science|September 19, 2018
Trend Analysis of FDA Warning Letters Issued to Medical Products About Violations to Current Good Manufacturing Practices (CGMP) Between 2007 and 2014Liqing Wang, Hang Zheng, Xiaohong Ren, et al.Therapeutic Innovation & Regulatory Science|September 19, 2018
Implementing Benefit-Risk Assessment for the Periodic Benefit-Risk Evaluation ReportMargaret R Warner, Anne M Wolka, Rebecca A NoelTherapeutic Innovation & Regulatory Science|September 19, 2018
Pharmaceutical Pricing and Reimbursement in Japan: For Faster, More Complete Access to New DrugsAkane Takayama, Mamoru NarukawaTherapeutic Innovation & Regulatory Science|September 19, 2018
A Paradigm Shift Towards Patient Involvement in Medicines Development and Regulatory Science: Workshop Proceedings and CommentaryGitte Borup, Karin Friis Bach, Merete Schmiegelow, et al.Therapeutic Innovation & Regulatory Science|September 19, 2018
Sterile Compounding Pharmacies: States That Do and Do Not Require Compliance With USP Versus FDA 483sMichelle WilsonTherapeutic Innovation & Regulatory Science|September 19, 2018
Implications of CRISPR-Based Germline Engineering for Cancer SurvivorsGregory Katz, Peter J PittsTherapeutic Innovation & Regulatory Science|September 20, 2018
Review of the Evolution of Medical Information in Light of Changes in the External LandscapeSuzana A Giffin, Peter Baumeister, David BowersTherapeutic Innovation & Regulatory Science|September 20, 2018
The Life Cycle and Management of Protocol DeviationsMunish Mehra, Katharina Kurpanek, Maryrose Petrizzo, et al.Therapeutic Innovation & Regulatory Science|September 20, 2018
Strategies for a Label Claim or Indication in the Context of Robust Point Estimates From Historical DataJin Wang, Roseann White, Lei PengPageof 165