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Authorized or Off-Label Use? A Structured Analysis of Summaries of Product Characteristics with Regard to Authorization in Pediatrics Markus HerzigSimone EisenhoferMartina Patrizia Neininger Original Research Article Open access 31 March 2024 Pages: 205 - 216
A Sponsor’s Perspective on the Contribution of Regulatory-Required Observational Post-Marketing Studies to Understanding Human Drug Product Benefit/Risk in Japan Kevin D. WolterAsayuki KamataniRod Junor Original Research Article Open access 31 March 2024 Pages: 217 - 224
Survey of Data Package and Sample Size of Comparative Clinical Studies for Biosimilar Developments from PMDA Assessments Ryosuke KuribayashiAya HariuYasuhiro Kishioka Original Research Article 29 April 2024 Pages: 225 - 239
Survey on the Situation of Medical Departments in the Pharmaceutical Industry in Spain Isabel Sanchez-MagroSusana Gomez-LusPablo Viguera Original Research Article Open access 21 March 2024 Pages: 241 - 250
Trends in Adverse Event Reporting Before and After the Introduction of the Med Safety App in Nigeria Uchenna Geraldine ElemuwaFraden BitrusChristiana Mojisola Adeyeye Original Research Article 06 May 2024 Pages: 251 - 259
