Goodwin’s 2025 Rare Disease Symposium, held on February 5 in Boston and virtually, gathered patient advocates and caregivers, providers, researchers, biotech and medtech leaders, investors, and policy experts to discuss the...more
2/26/2025
/ Biotechnology ,
Food and Drug Administration (FDA) ,
Funding ,
Health Care Providers ,
Healthcare ,
Innovation ,
Life Sciences ,
Med Tech ,
Medical Research ,
Pharmaceutical Industry ,
Public Policy ,
Public Private Partnerships (P3s)
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more
10/1/2024
/ Biden Administration ,
Biologics ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Diversity ,
Draft Guidance ,
EU ,
European Medicines Agency (EMA) ,
Executive Orders ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Information Reports ,
Laboratory Developed Tests ,
Life Sciences ,
Med Tech ,
Medical Research ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
New Guidance ,
OCR ,
Pediatrics ,
Pending Legislation ,
Personal Data ,
Pharmaceutical Industry ,
Scientific Research ,
UK
The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more
7/25/2024
/ Clinical Trials ,
Compliance Monitoring ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Government Investigations ,
Inspections ,
Institutional Review Board (IRB) ,
Investigations ,
Medical Devices ,
Medical Research ,
Scientific Research ,
Statutory Violations ,
Warning Letters
Yesterday, the U.S. Food and Drug Administration (FDA) released its long-awaited draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies....more
In Draft Guidance published this week by the U.S. Food and Drug Administration (FDA), Guidance for Industry – Processes and Practices Applicable to Bioresearch Monitoring Inspections, the Agency provides some wisdom on best...more
The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more
7/12/2023
/ Audits ,
Biotechnology ,
Clinical Trials ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Inspections ,
Institutional Review Board (IRB) ,
Investigational New Drug Application (IND) ,
Life Sciences ,
Medical Devices ,
Medical Research ,
Pharmaceutical Industry ,
Sponsors