Elaine Tseng

Elaine Tseng

King & Spalding

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FDA Issues New Draft Guidance for Sponsors on Safety Event Analysis and Reporting for IND and Bioavailability/Bioequivalence...

Focuses on Aggregate Safety Data Analysis and Expedited Reports; Expectation for Prospective Safety Surveillance Plan - The Food and Drug Administration (FDA) has issued a new draft guidance (the Draft Guidance) that...more

7/27/2021  /  Clinical Trials , Draft Guidance , FDA , Final Rules , Investigational New Drug Application (IND) , New Guidance , Sponsors

The End of Enforcement Discretion for Cell & Gene Therapies: Thinking Through Next Steps

Beginning this week, the U.S. Food and Drug Administration (“FDA”) ended its compliance and enforcement discretion policy with regard to certain human cell, tissue, and cellular and tissue-based products (“HCT/Ps”). HCT/P...more

6/4/2021  /  Center for Biologics Evaluation and Research (CBER) , FD&C Act , FDA , Human Genes , Investigational New Drug Application (IND) , PDUFA , Public Health Service Act

FDA Reverses HHS Exemption of Class I and Class II Medical Devices from Section 510(k)

Premarket Notification Again Required for Patient and Surgeon's Examination Gloves and Dozens of Class II Devices Proposed for Exemption by Former HHS Secretary - On April 16, 2021, the Food and Drug Administration (“FDA”...more

4/21/2021  /  Department of Health and Human Services (HHS) , Exemptions , FD&C Act , FDA , Federal Register , Medical Devices , Pre-Market Notification , Public Health Emergency , Public Notice

FDA Appoints Renowned Cybersecurity Researcher to Head Agency's Medical Device Cybersecurity Efforts

Earlier this week, FDA’s Center for Devices and Radiological Health (CDRH) announced the appointment of Professor Kevin Fu, Associate Professor at the University of Michigan, as the Center’s first Acting Director of Medical...more

2/5/2021  /  Administrative Appointments , CDRH , Cybersecurity , FDA , Medical Devices

Federal Government Takes Steps Toward Enforcement of ClinicalTrials.gov Requirements

Time Is Ripe To Update SOPs And To Ensure Compliance with Results Submission Requirements - In recent days, the federal Department of Health and Human Services (“HHS”) clarified the requirements for submission of certain...more

8/20/2020  /  Civil Monetary Penalty , Clinical Trials , Compliance , Corrective Actions , Department of Health and Human Services (HHS) , FDA , Federal Register , Medical Devices , National Institute of Health (NIH) , Prescription Drugs

U.S. and EU Regulators and Institutions Issue Guidance on Clinical Trial Conduct during COVID-19 Pandemic

The Food and Drug Administration (“FDA”) as well as the European Medicines Agency (“EMA”) and the national Heads of Medicines Agencies (“HMA”) issued new guidance for industry sponsors, investigators, and Institutional Review...more

3/27/2020  /  Clinical Trials , Coronavirus/COVID-19 , EU , Health Care Providers , Life Sciences , New Guidance , Patient Safety

U.S. District Court Overturns HHS Interpretation of Final Rule that Permitted Sponsors of Certain Drug and Device Trials to Avoid...

If Sustained, Court Decision Will Require Disclosure of Results for a Decade of Certain Clinical Trials - Section 801 of the Food and Drug Administration Amendments Act of 2007 (“Section 801”), which is codified at 42...more

3/4/2020  /  Article III , Clinical Trials , Department of Health and Human Services (HHS) , FDA , Federal Rule 12(b)(1) , Final Rules , Food and Drug Administration Amendments Act (FDAAA) , Motion for Summary Judgment , National Institute of Health (NIH) , Pharmaceutical Industry , Preamble , Public Health Service Act , Retroactive Application , Rules of Appellate Procedure , Standard of Review , Standing

2019 Year in Review: FDA Office of Prescription Drug Promotion

In 2019, the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) issued a total of ten enforcement letters targeting advertising and promotion violations for prescription drugs. Of the ten...more

3/2/2020  /  FDA , Manufacturers , Off-Label Promotion , OPDP , Pharmaceutical Industry , Prescription Drugs , Warning Letters

FDA Releases Draft Guidance on Promotion of Biological Reference and Biosimilar Products

Part of a New Joint Initiative with FTC to Deter Anti-Competitive Practices, Including False or Misleading Comparisons - On February 3, 2020, the U.S. Food and Drug Administration (“FDA”) released draft guidance providing...more

2/10/2020  /  Anti-Competitive , Biologics , Biosimilars , Clinical Trials , Comment Period , Draft Guidance , False Advertising , FDA , FTC , Labeling , Misleading Statements , Prescription Drugs , Public Comment

FDA Issued Draft Objective Performance Criteria For Five Device Types

Implications for 510(k) Submissions - On September 20, 2019, FDA issued four separate draft guidance documents for industry and FDA administration staff that provide extensive objective performance criteria (OPC) for five...more

9/27/2019  /  510(k) RTA , Draft Guidance , FDA , Life Sciences , Medical Devices , Pharmaceutical Industry , Premarket Approval Applications , Safety and Performance Pathway

FDA Proposes Regulatory Framework for Artificial Intelligence/Machine Learning Software as a Medical Device

On April 2, 2019, the U.S. Food and Drug Administration (“FDA” or “Agency”) proposed a new regulatory framework to address the development and marketing of artificial intelligence and machine learning-based software as a...more

4/10/2019  /  Algorithms , Artificial Intelligence , Comment Period , FDA , Healthcare , Healthcare Facilities , Medical Devices , Popular , Public Comment , Regulatory Agenda , Software

FDA Tackles Digital Health Software Devices with New Pre-Certification Review Plan

On January 7, 2019 the U.S. Food and Drug Administration (“FDA”) issued three new documents related to the Agency’s Software Precertification (“Pre-Cert”) Pilot Program. These documents include (1) the Developing a Software...more

1/23/2019  /  Comment Period , Cybersecurity , Digital Health , FDA , Life Sciences , Medical Devices , Mobile Medical Applications , Popular , PreCert Pilot Program , Precertification , Public Comment , Software , Telemedicine

FDA Announces “Modernization” Reforms to Medical Device Review Process

FDA Announces Intent to Modernize the Medical Device Review Process that Would Discourage Reliance on Older Devices as Predicates for the 510(k) Process - Last week FDA released two statements announcing plans and...more

12/4/2018  /  510(k) RTA , FDA , Medical Devices , National Evaluation System for Health Technology (NEST)

FDA and Life Sciences FDA Finalizes Guidances for “Consistent Communications” and Payor Communications

A Summary of Final Guidances for Communications That Are Consistent with FDA-Required Labeling and Communications with Payors - On June 12, 2018, the Food and Drug Administration (FDA or Agency) finalized two draft...more

6/21/2018  /  FDA , Final Guidance , First Amendment , HCEI , Labeling , Life Sciences , Manufacturers , Medical Devices , Off-Label Use , Pharmaceutical Industry , Prescription Drugs , Required Communications , Safe Harbors

2017 Year in Review: FDA Office of Prescription Drug Promotion Warning and Untitled Letters

In 2017, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued a total of five enforcement letters that cited violations related to the advertising and promotion of prescription...more

2/28/2018  /  Enforcement , FDA , Pharmaceutical Industry , Prescription Drugs , Warning Letters

FDA Considers Approval Pathway for Medical Devices to Unilaterally Cross-Reference Marketed Drug Products

Would Not Require Collaboration by the Drug Sponsor; FDA Requests Comments on Potential Approach - The Food and Drug Administration (FDA) requests comment on a potential approval pathway for “ devices referencing drugs”...more

12/19/2017  /  FDA , FDCA , Medical Devices , Pharmaceutical Industry

The Age of Competition - The Supreme Court Decides the First BPCIA Case

In a landmark ruling for the biotech and pharmaceutical industries, a unanimous Supreme Court decided Sandoz Inc. v. Amgen Inc., 582 U.S. ____, Nos. 15-1039, 15-1195 (June 12, 2017), its first biosimilar case governed by the...more

6/14/2017  /  aBLA , Biotechnology , BPCIA , Confidential Information , Opt-Outs , Patent Dance , Patents , Pharmaceutical Industry , Sandoz v Amgen

HHS Issues Final Rule that Substantially Revises the Federal Policy for the Protection of Human Subjects

On January 19, 2017, the Department of Health and Human Services (HHS) and fifteen other Federal departments and agencies published a final rule that extensively revises and modernizes the Federal Policy for the Protection of...more

2/2/2017  /  21st Century Cures Act , Department of Health and Human Services (HHS) , FDA , Final Rules , Informed Consent , Life Sciences , Research and Development , The Common Rule

FDA Defends Its First Amendment Position in “Memorandum”

On January 18, 2017, the Food and Drug Administration (FDA or the Agency) released for public comment a Memorandum, Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding...more

1/26/2017  /  Draft Guidance , FDA , First Amendment , Off-Label Promotion , Pharmaceutical Industry , Public Comment

FDA Issues Draft Guidance Addressing Communications with Payors

On January 18, the Food and Drug Administration (FDA or the Agency) issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers. This...more

1/23/2017  /  21st Century Cures Act , Draft Guidance , FD&C Act , FDA , FDAMA , HCEI , Investigational New Drug Application (IND) , Manufacturers , Material Dissemination , Payor Contracts , Safe Harbors , Section 502

FDA Issues Discussion Paper on LDTs

Following its recent announcement that it would not finalize its 2014 draft guidance on laboratory developed tests (“LDTs”), the U.S. Food and Drug Administration (“FDA”) issued a Discussion Paper on Laboratory Developed...more

1/21/2017  /  Centers for Medicare & Medicaid Services (CMS) , CLIA , Draft Guidance , FDA , Laboratory Developed Tests

FDA Takes Action in the Last Days of the Obama Administration to Clarify Some of Its Views on Off-Label Communications

In the last few days of the Obama Administration, the Food and Drug Administration (FDA or the Agency) issued a number of documents with implications for manufacturer communications with health care practitioners and payors. ...more

1/20/2017  /  FDA , Health Care Providers , Labeling , Manufacturers , Obama Administration , Off-Label Use

FDA Launches Form for Reporting Allegations of Misconduct by Device Manufacturers

Program Has Broad Reach - On October 21, 2016, the Food and Drug Administration launched a webpage that contains an Allegations of Regulatory Misconduct Form to enable whistleblowers, competitors, and others to report...more

11/1/2016  /  FDA , Manufacturers , Medical Devices , Willful Misconduct

HHS Issues Final Rule that Expands the Requirements for Disclosure of Clinical Trial Data to ClinicalTrials.gov

On September 21, 2016, the Department of Health and Human Services (HHS) published a final rule that greatly expands the information that sponsors of “applicable drug clinical trials” and “applicable device clinical trials”...more

10/27/2016  /  Adverse Events , Civil Monetary Penalty , Clinical Trials , Department of Health and Human Services (HHS) , Disclosure Requirements , Enforcement , FDA , FDCA , Final Rules , Food and Drug Administration Amendments Act (FDAAA) , Good Cause , Medical Devices , Penalties , Pharmaceutical Industry , Public Access Laws , Public Health Service Act

FDA Finalizes Wellness Product Guidance

The Food and Drug Administration Safety Innovation Act of 2012 (“FDASIA”) required a collaborative effort by the Food and Drug Administration (“FDA”), Federal Communications Commission and Office of the National Coordinator...more

8/13/2016  /  FCC , FDA , FDASIA , Final Guidance , General Wellness Devices , Health Information Technologies , Medical Devices
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JD Supra Privacy Policy

Updated: Apr 27, 2021:

JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.

This Privacy Policy describes how JD Supra, LLC ("JD Supra" or "we," "us," or "our") collects, uses and shares personal data collected from visitors to our website (located at www.jdsupra.com) (our "Website") who view only publicly-available content as well as subscribers to our services (such as our email digests or author tools)(our "Services"). By using our Website and registering for one of our Services, you are agreeing to the terms of this Privacy Policy.

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Links to Other Websites

Our Website and Services may contain links to other websites. The operators of such other websites may collect information about you, including through cookies or other technologies. If you are using our Website or Services and click a link to another site, you will leave our Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We are not responsible for the data collection and use practices of such other sites. This Policy applies solely to the information collected in connection with your use of our Website and Services and does not apply to any practices conducted offline or in connection with any other websites.

Information for EU and Swiss Residents

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

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You can make a request to exercise any of these rights by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

You can also manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard.

We will make all practical efforts to respect your wishes. There may be times, however, where we are not able to fulfill your request, for example, if applicable law prohibits our compliance. Please note that JD Supra does not use "automatic decision making" or "profiling" as those terms are defined in the GDPR.

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California Privacy Rights

Pursuant to Section 1798.83 of the California Civil Code, our customers who are California residents have the right to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes.

You can make a request for this information by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

Some browsers have incorporated a Do Not Track (DNT) feature. These features, when turned on, send a signal that you prefer that the website you are visiting not collect and use data regarding your online searching and browsing activities. As there is not yet a common understanding on how to interpret the DNT signal, we currently do not respond to DNT signals on our site.

Access/Correct/Update/Delete Personal Information

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Changes in Our Privacy Policy

We reserve the right to change this Privacy Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our Privacy Policy will become effective upon posting of the revised policy on the Website. By continuing to use our Website and Services following such changes, you will be deemed to have agreed to such changes.

Contacting JD Supra

If you have any questions about this Privacy Policy, the practices of this site, your dealings with our Website or Services, or if you would like to change any of the information you have provided to us, please contact us at: privacy@jdsupra.com.

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How We Use Cookies and Other Tracking Technologies

We use cookies and other tracking technologies to:

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There are different types of cookies and other technologies used our Website, notably:

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JD Supra Cookies. We place our own cookies on your computer to track certain information about you while you are using our Website and Services. For example, we place a session cookie on your computer each time you visit our Website. We use these cookies to allow you to log-in to your subscriber account. In addition, through these cookies we are able to collect information about how you use the Website, including what browser you may be using, your IP address, and the URL address you came from upon visiting our Website and the URL you next visit (even if those URLs are not on our Website). We also utilize email web beacons to monitor whether our emails are being delivered and read. We also use these tools to help deliver reader analytics to our authors to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

Analytics/Performance Cookies. JD Supra also uses the following analytic tools to help us analyze the performance of our Website and Services as well as how visitors use our Website and Services:

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If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

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Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

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