News
- Impacts of the EU IVDR Survey Report (03/2024)
- Alternative Animal Testing Report is out (03/2024)
- 3Rs Working Party (3RsWP) Plenary Meeting (03/2024)
- Chairs Rodgers and Guthrie Announce Health Subcommittee Hearing on Regulation of Diagnostic Tests (03/2024)
- Health Subcommittee Hearing: “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule” (03/2024)
- Providing Regulatory Submissions in Electronic Format: IND Safety Reports (04/2024)
- In-Silico Breakthrough: EMA’s Shift from Animal Testing (05/2024)
- ICH Harmonized Guideline Drug Interaction Studies M12 (05/2024)
- FDA Clinical Trial Requirements, Regulations, Compliance, and GCP Conference (06/2024) FDA
- FDA WORKSHOP: 9th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop (06/2024) FDA
- Laboratory Developed Tests: Small Entity Compliance Guide (06/2024) FDA
- In Vitro Toxicology Testing Market Size (06/2024)
- 3D Cell Culture Market Size (06/2024)
- Webinar - In Vitro Diagnostic Products (IVDs) - MDR Requirements, Correction and Removal Reporting Requirements, and Quality System Complaint Requirements (08/2024)
- M12 Drug Interaction (08/2024)
- M12 Drug Interaction Questions and Answers (08/2024)
- Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases (08/2024)
- Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products (10/2024)