1 Hour and 30 Minute Video | Elaine Tseng, King & Spalding LLP’s FDA and Life Sciences Group
The medical device industry has recently seen a spike in companies conducting clinical studies outside the US (OUS) due to limitations in time, money, and other resources, combined with stringent FDA guidelines for US studies. However, FDA’s device regulations largely do not address or clarify requirements for assuring the acceptability of data from OUS studies to support US research or marketing applications. Additionally, there are inconsistencies in FDA’s device regulations regarding information to be provided about US clinical studies in different types of FDA applications. To address these issues and better harmonize regulatory expectations for clinical studies, whether conducted inside or outside the US, and whether used to support a FDA premarket approval application (PMA), premarket notification (510(k)), or investigational device exemption (IDE) submission, FDA recently issued a proposed rule -open for comment until May 28, 2013 – that would amend various parts of its device regulations. If finalized, these proposed amendments will significantly alter what companies must do to successfully use data generated abroad in support of FDA applications and submissions; it will also have new impacts for companies submitting US clinical data in support of FDA submissions.
- FDA’s proposed requirement that clinical studies conducted outside the US be compliant with good clinical practices (GCP), including how FDA proposes to define GCP
- What companies would need to do to demonstrate GCP compliance when seeking to rely on foreign data in FDA submissions, including 510(k)s and IDEs
- The proposed rule’s implications for US-based clinical data submitted in FDA applications
- Practical considerations and strategies in light of the proposed rule
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Clinical Affairs and Operations
- Clinical Coordinator
- Regulatory Affairs
- GCP Compliance
King & Spalding
FDA & Life Sciences Practice Group
Elaine Tseng, Partner, King & Spalding-FDA & Life Sciences Practice Group
Elaine H. Tseng is a Partner in King & Spalding LLP’s FDA and Life Sciences group in San Francisco, California. Ms. Tseng previously served as Regulatory Counsel at the Food and Drug Administration. In her practice, Ms. Tseng specializes in FDA matters, including the regulatory requirements and policies applicable to medical devices and the companies that manufacture, market, and/or distribute them. Ms. Tseng has expertise in medical device regulation in the areas of clinical trials, FDA clearance and approval, postmarket compliance, and FDA inspections. She has aided companies in developing regulatory strategies for bringing products to market, creating policies and programs to ensure regulatory compliance, evaluating the reportability of adverse events or product changes, performing FDA due diligence reviews, and conducting internal investigations of alleged or potential regulatory noncompliance. Ms. Tseng also assists companies in responding to inspectional observations, Warning Letters, integrity holds, and other FDA enforcement actions. In addition, she has significant experience facilitating companies’ interactions with FDA, including preparing regulatory appeals, assisting companies in preparing for and participating in Advisory Committee meetings, and preparing or opposing citizen petitions, reclassification petitions, and other petitions requesting regulatory actions. She is a frequent speaker and writer on topics related to FDA regulation. Ms. Tseng is a graduate of Cornell University and Harvard Law School. She is also a recipient of the Secretary for Health and Human Services’ Distinguished Service Award and other FDA honors.