Jennifer Stohlmann

Biography

Jenny Stohlmann, RAC is a regulatory specialist whose expertise spans the complete product lifecycle for prescription and over-the-counter human and animal drugs, biologics, and devices. As a member of Loeb & Loeb’s FDA Regulatory & Compliance team, she has up-to-date knowledge of a wide range of FDA and FTC guidance documents and has performed extensive analyses of FDA, OIG and DOJ enforcement activity related to the commercialization of FDA-regulated products.

Ms. Stohlmann fosters a culture of compliance and translates formal Compliance Programs into compliant day-to-day activities. Her experience extends from detailed legal research and drafting of policies to operationalization and system implementation in the live business environment. She performs compliance management of commercial system vendors and 3PLs and participates on commercial product launch teams. Ms. Stohlmann crafts compliance trainings for home office personnel, field forces, and vendors on topics ranging from prescription drug sampling to speaker programs to medical communications.

Ms. Stohlmann has demonstrated knowledge of the regulatory and compliance obligations of manufacturers and distributors under: FDCA, PDMA, User Fee Acts, FDAMA, FDAAA, FDASIA, PPACA, and Title 21 of the Code of Federal Regulations.


Prior Experience

Ms. Stohlmann was previously with Porzio, Bromberg, and Newman P.C., and select examples of her work experience include the following:

  • Completion and submission of formal communications, regulatory filings, and reports to Federal and State agencies.

  • Preparation of required disclosure logs under an OIG Corporate Integrity Agreement.

  • Performance of gap analyses and remediation of audit deficiencies.

  • Researching standards of substantiation and required disclosures for specific product claims for drugs, medical devices, cosmetics, and dietary supplements in support of commercial and regulatory strategies.

  • Surveying state laws and regulations in areas of rapid legislative change, such as: manufacturer/distributor/wholesaler licensing, pharmaceutical marketing and advertising disclosure requirements, and midlevel prescriber licensing.

  • Support of legal-medical-regulatory review processes for scientific and promotional materials.

  • Completion of regulatory due diligence for life sciences transactions.

Affiliations

  • Member, Regulatory Affairs Professional Society

Publications

  • Author, FDA Regulatory and Compliance Monthly Recap — October 2016 (October 2016)

  • Author, FDA Regulatory and Compliance Monthly Recap — September 2016 (September 2016)

  • Author, FDA Regulatory and Compliance Monthly Recap — August 2016 (August 2016)

  • Author, FDA Regulatory and Compliance Monthly Recap — July 2016 (July 2016)

  • Author, FDA Regulatory and Compliance Monthly Recap – June 2016 (June 2016)

  • Author, FDA Regulatory and Compliance Monthly Recap – May 2016 (May 2016)

  • Author, FDA Regulatory and Compliance Monthly Recap — April 2016 (April 2016)

  • Author, FDA Regulatory and Compliance Monthly Recap — March 2016 (March 2016)

  • Author, FDA Regulatory and Compliance Monthly Recap — February 2016 (February 2016)

Education

Regulatory Affairs Certification Board, Regulatory Affairs Certification (United States)

Regulatory Affairs Professional Society, Regulatory Affairs Certificate Program, Medical Devices and Pharmaceuticals (Dual)

Pratt Institute, B.F.A. in Writing

President's List, Department Honor for Academic Excellence





Practice Areas

  • Corporate Law
  • Health Care Law

3 Courses by Jennifer Stohlmann