Charles G. Raver Associate 202-900-2801
Charles G. Raver

Overview

Charles G. Raver assists clients across a range of FDA-related regulatory matters by providing timely strategic advice on new drug and biologic development and helping them tackle complex regulatory issues.  His practice supports clients throughout the life sciences from biotech startups and multinational pharmaceutical companies to CROs and academic researchers to patient advocacy organizations.  Mr. Raver joined Hyman, Phelps & McNamara after more than a decade in biomedical research spent studying the neurobiological mechanisms of chronic pain and sensory processing.  He now leverages his deep knowledge of the drug development ecosystem and background in neuroscience, pre-clinical animal research and study design to help clients navigate the regulatory landscape faced by the life sciences industry.

Mr. Raver graduated with honors from the University of Maryland Carey School of Law.  While in law school, Mr. Raver served as a staff editor and the first social media chair for the Journal of Health Care Law & Policy.  He also received two CALI awards after nabbing the top grade in courses on Animal Law and Written and Oral Advocacy.  Throughout law school, Mr. Raver continued his neurobiology research career full-time. His research has resulted in nine original peer-reviewed research publications demonstrating potential therapeutic targets for treating chronic pain and revealing functions of neural circuits responsible for sensory processing.  Mr. Raver also has extensive knowledge and direct experience with the advanced techniques driving development of current biomedical therapies, such as optogenetics, chemogenetics, viral vector-mediated gene delivery, and targeted stimulation techniques

Education & Admissions

Education

J.D., University of Maryland Carey School of Law, 2020, cum laude
B.S., Davidson College, 2007

Admissions

District of Columbia
Maryland

Experience

Prescription Drugs and Biologics

  • Advises clients throughout product development from preclinical investigational stages to clinical development to NDA and BLA submission and review to post-action appeal, response, and resubmission.
  • Assists clients to request, prepare for and successfully navigate formal meetings with FDA.
  • Provides strategic advice on interactions with and regulatory submissions to FDA.

Corporate Transactions

  • Conducts due diligence and advises clients with regards to FDA and USDA regulatory requirements during asset acquisitions and securities filings.

Litigation and Enforcement Matters

  • Drafts arguments for court filings and white papers regarding FDA regulatory requirements, legal authority and enforcement policy as well as the intersection of federal and state authority to regulate consumer products that fall under FDA regulatory authority.

Honors & Awards

CALI Excellence for the Future Awards – Written and Oral Advocacy (2017), Environmental Law Seminar: Animal Law (2019)

Speaking Engagements

  • Panelist, ACI’s Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities, Bridging the Gap: From Pre-Commercialization Research to Regulatory Approval for Novel Therapeutics and Regenerative Medicines, March 20-21, 2024
  • Session Chair, DIA 2023 Global Annual Meeting – ILLUMINATE, 25-Years After FDAMA: How is FDA Applying the Confirmatory Evidence Standard for Substantial Evidence of Effectiveness?, June 25-29, 2023
  • FDLI/USAMRDC Virtual Training Course Introduction to Drug Law and Regulation, Presenter: The New Drug Approval Process: NDA Submission and Review, June 27-28, 2022
  • FDLI Introduction to Drug Law and Regulation Course, The New Drug Approval Process: NDA Submission and Review, April 27-28, 2022 (Virtual)
Education

J.D., University of Maryland Carey School of Law, 2020, cum laude
B.S., Davidson College, 2007

Admissions

District of Columbia
Maryland

Practice Areas
Industries
FDA Regulatory Categories