ABOUT H. CARL JENKINS

Since joining the Wood Burditt Group in the spring of 2007, Carl’ s practice has been focused on FDA, USDA and EPA regulatory law.

Carl’s areas of practice include drugs, medical devices, foods, and cosmetics. He has worked with numerous companies on premarket notification submissions to FDA for devices (510(k)s); premarket approval submissions to FDA for devices (PMAs); Investigational Device Exemption applications (IDEs); compliance with FDA’s OTC drug monographs; NDAs and ANDAs for drugs; compliance with FDA’s marketing, promotion and labeling regulations; compliance with FDA’s medical device Quality Systems Regulation (QSRs) and current good manufacturing practice requirements for drugs and foods; facility inspections; 483s, Warning Letters and consent decrees; and enforcement action resolution.

In addition, Carl has extensive experience working with covered entities and business associates on compliance and contract matters under HIPAA, the HITECH Act, and the Privacy, Security, Breach Notification, and Enforcement Rules at 45 CFR Part 160 and Part 164. Carl also has experience with CMS reimbursement issues. As part of his practice, Carl has also advised clients on FDA combination product matters, the importation and exportation of FDA regulated products, USDA’s National Organic Program regulations, FDA Office of Criminal Investigations, precursor chemical and controlled substance laws, and advertising matters before the Federal Trade Commission and the National Advertising Division (NAD) of the Better Business Bureau. Carl’s practice also includes EPA matters under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), in addition to state regulation of pesticide products.

EXPERIENCE

  • FDA and FTC Promotional and Labeling Matters
  • FDA’s CGMP / QSR Requirements for Food, Drugs and Devices
  • OTC Drug Product Monograph Compliance
  • 505(b)(1), 505(b)(2), 505(j) NDAs for New Drug Products
  • FD&C Act and FPLA Cosmetic Marketing Regulations
  • DSHEA Dietary Supplement Regulations
  • 510(k), PMA, IDE Medical Device Submissions
  • Clinical and Animal Trials of FDA Regulated Articles
  • Combination Products
  • FDA Inspections
  • Importation and Exportation of FDA Regulated Products
  • HIPAA, the HITECH Act, and the Privacy, Security, Breach Notification, and Enforcement Rules at 45 CFR Part 160 and Part 164
  • CMS Reimbursement
  • FDA Office of Criminal Investigations
  • USDA Organic Foods Regulations
  • Federal and State Controlled Substance and Precursor Chemical Laws
  • State Poison Regulations
  • EPA Pesticide Matters
  • FDA and EPA Registration and Listing

EDUCATION

  • DePaul University College of Law, Chicago, Illinois
    Juris Doctor, conferred May 2006
  • Colby College, Waterville, Maine Bachelor of Arts, conferred May 1998

ADMISSIONS

  • Illinois