28 JanuarySPS Webinar Invite: January 30, 2020 (11 AM ET) Dear Colleagues, The Safety Pharmacology Society is pleased to invite you to a webinar p... read more
28 JanuaryWith deepest condolences: Carrie G. Markgraf, MD, PhD We would like to express our deepest sympathy on the passing of president of Safety Pharmacology ... read more
27 JanuarySPS Succession Plan We were deeply saddened when we learned of Carrie Markgraf’s passing at the beginning of the ... read more
27 JanuaryIn Memoriam: Ian MacKenzie, PhD It is with great sadness that we share the passing of SPS Past-President Ian MacKenzie, PhD on... read more
10 JanuaryIn Memoriam: Carrie G. Markgraf, MD, PhD June 18, 1960 – January 2, 2020 It is with heavy hearts that we share the passing of SPS ... read more
18 DecemberSPotlight Newsletter—Winter Issue Winter 2019 View Full Issue Take a moment to catch up on SPS ... read more
27 FebruaryE2B(R3) The Electronic Transmission of Individual Case Safety Reports Implementation Guide —Appendix to the Implementation Guide — Backwards and Forwards CompatibilityThis document is an appendix to the Implementation Guide (IG) for the ‘International Conference on H... read more
27 FebruaryQuality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product Guidance for IndustryQuality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Referenc... read more
27 FebruaryFDA Regional Implementation Specifications for ICH E2B(R3) ImplementationThis technical specifications document is to assist interested parties in electronically submitting ... read more
27 FebruaryClinical Drug Interaction Studies — Study Design, Data Analysis, and Clinical Implications Guidance for IndustryThis guidance helps sponsors of investigational new drug applications and applicants of new drug 17 ... read more
27 FebruaryEstablished Conditions: Reportable CMC Changes for Approved Drug and Biologic Products Guidance for IndustryThis guidance has been developed to address the lack of clarity with respect to what chemistry, 17 m... read more
27 FebruaryImmunotoxicology Evaluation of Investigational New DrugsThis guidance makes recommendations to sponsors of investigational new drugs (INDs) on (1) the param... read more
