Linda Jong

Role: Regulatory Counsel at the Center for Drug Evaluation and Research, Office of Regulatory Policy at FDA
Location: Washington, DC, US
LinkedIn followers: 500 followers

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About Linda Jong

Regulatory lawyer with over 13 years of experience in drug law and policy at the FDA\'s…

Experience

Regulatory Counsel at the Center for Drug Evaluation and Research, Office of Regulatory Policy
FDA
Oct 2011 — Present · Silver Spring, MD, US
Drug law and policy expert that developed drug regulations, drafted legally sufficient responses to citizen petitions (formal requests that FDA take specific actions), and presented complex drug policy matters to FDA leadership.• Provided legal/regulatory counsel on issues including, but not limited to, investigational new drug application reports, over-the-counter (OTC) monograph drugs, postapproval drug application reports, drug safety, drug product labeling, quality metrics, Current Good Manufacturing Practice, and the Generic Drug User Fee Amendments.• Developed approaches to address complex legal/regulatory issues impacting review of drug applications consistent with the Federal Food, Drug and Cosmetic Act and the Administrative Procedure Act, including FDA’s first additional condition for nonprescription use (ACNU) new drug application. • MoCRA (Modernization of Cosmetics Regulation Act of 2022) Implementation Working Group Member. CDER’s lead for cosmetic-drug issues.• OTC Monograph Reform Legal/Policy Team Member.

Skills

Policy
Community Outreach
Epidemiology
Microsoft Office
Legal Writing
Outlook
Analysis
Powerpoint
Legal Research
Legislation
Public Policy
Non-Profits
Writing
Research
Editing
Health Law
Government
Nonprofits
Policy Analysis
Grant Writing
Public Health
Health
Word
Healthcare

Contact information

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Work email
•••••@fda.gov
Personal email
•••••@•••••.com
Direct dial
+16•••••••74

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Current company

FDA

Government Administration · 18K employees · Silver Spring, Maryland, United States

The Food and Drug Administration is an agency within the Department of Health and Human Services. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

fda.gov

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About Linda Jong

Experience

Regulatory Counsel at the Center for Drug Evaluation and Research, Office of Regulatory Policy

Skills

Find verified contacts for anyone on LinkedIn