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
As the life sciences industry continues to expand and grow increasingly complex, so does its legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and...more
6/30/2023
/ Biologics ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Marketing ,
Marketing Authorization Application ,
Med Tech ,
Medicaid ,
Medical Devices ,
Medicare ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs
On May 2, 2023, the U.S. Food and Drug Administration (“FDA”) published draft guidance titled “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” (the “Draft Guidance”). ...more
The U.S. Food and Drug Administration (FDA) recently finalized its guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations” (the “2023 RBM Guidance”) which follows up on the Agency’s March 2019 draft...more
Clinical trial diversity is not a new concept–the U.S. Food and Drug Administration (FDA) issued a draft guidance providing specific recommendations to industry on how to improve diversity in clinical trials in April 2022...more
Investigators interested in rare disease treatment development have the opportunity to approach drug and biologic developers to obtain investigational drug supply for trials in which the investigators, typically at academic...more
For sponsors utilizing a data monitoring committee in their trial designs to monitor for emerging safety signals, lack of effect, and/or futility of treatment, understanding data monitoring committee conflict of interest...more
The Bioresearch Monitoring Program (BIMO), run by the U.S. Food and Drug Administration (FDA), oversees the conduct of on-site inspections and data audits of FDA-regulated research in support of new product development and...more
6/29/2022
/ Audits ,
Clinical Trials ,
Compliance ,
Dietary Supplements ,
Food and Drug Administration (FDA) ,
Investigational New Drug Application (IND) ,
Prescription Drugs ,
Regulatory Violations ,
Research and Development ,
Sponsors ,
Warning Letters
Last week the U.S. Food and Drug Administration (FDA) issued a long-awaited draft guidance, Human Gene Therapy Products Incorporating Human Genome Editing, that addresses key considerations for the development of gene therapy...more
During the COVID-19 pandemic, decentralized clinical trials and remote patient monitoring and data acquisition became a necessity, accelerating the use of digital health technologies in clinical trials. Acknowledging that...more
Last week the FDA issued another draft guidance in its series of recent guidance documents setting forth the agency’s views regarding the generation and use of Real-World Data (RWD) and Real-World Evidence (RWE) for...more
Showing no signs of food coma, the FDA issued draft guidance on the Monday following the Thanksgiving holiday weekend that outlines considerations for sponsors proposing to design a registry or use an existing registry to...more
The U.S. Food and Drug Administration’s (FDA’s) Office of Bioresearch Monitoring Operations (OBIMO) oversees domestic and foreign agency field inspections for clinical and non-clinical research. In particular, OBIMO manages...more
Developing a new drug or biologic is a complex process. Based on our extensive experience advising early-stage and clinical-stage companies, the Goodwin FDA team created this “scorecard” for companies to use as a guide as...more