The U.S. Food and Drug Administration (FDA) now provides a list of Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices that are legally marketed in the United States. These include devices (1) cleared via 510(k) premarket notifications, (2) authorized pursuant to De Novo requests, and (3) approved via premarket approval applications, or…
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 the Bioresearch Monitoring (BIMO) Program which conducts onsite field inspections and data monitoring to ensure institution and industry compliance with FDA’s…
The Biden Administration’s withdrawal of the Trump Administration’s proposal to exempt 84 medical device types from the FDA’s premarket notification, or 510(k), requirement, underscores the promotional framework that developers and marketers of these devices are subject to. The Trump Administration proposal included devices critical to combating the COVID-19 public health…
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 they navigate the FDA drug development and approval process. The drug development scorecard (or checklist)…
On May 19, 2021, the U.S. Food and Drug Administration (FDA) released an updated guidance in draft form on how to complete the Statement of Investigator form (Form FDA 1572). The guidance addresses frequently asked questions from sponsors, clinical investigators, and institutional review boards (IRBs), and it provides new information…
Goodwin Life Sciences and Healthcare partner Roger Cohen and associate Anne Brendel along with Life Sciences and FDA associate Steven Tjoe kicked off Goodwin’s multi-part webinar series “Disrupt + Innovate + Transform: A Healthcare Webinar Series” with “Key Regulatory Issues for Digital Health Companies” discussing the key regulatory issues affecting…
Given the breadth of clinical-stage companies that the Goodwin FDA and Healthcare teams advise, our regulatory attorneys together with our commercial contracting, products liability and insurance attorneys play an integral role in counseling clinical-stage companies on matters related to the conduct of clinical trials. Learn more about our…
On February 3, 2021 Goodwin FDA Regulatory partner, Julie Tibbets, Products Litigation + Counseling partner, Nilda Isidro, and Risk Management & Insurance counsel Brian Mukherjee discussed what drug and biologic companies with late-stage product candidates can do to best position their products to mitigate the risks that come with transitioning from clinical trials to…
On January 19, 2021, the FDA issued guidance for licensed and investigational cellular and gene therapy (CGT) manufacturers during the COVID-19 pandemic. This new guidance supplements the recommendations provided in FDA’s June 2020 guidance regarding manufacturing controls to prevent contamination in drugs, risk assessment of SARS-CoV-2 as it relates to…
On January 12, 2021, the U.S. Food and Drug Administration (FDA) published its Action Plan for further development of the Agency’s framework for regulatory oversight of artificial intelligence (AI) and machine learning (ML) based Software as a Medical Device (SaMD). The Action Plan identifies several opportunities for SaMD developers to…
