- Assisted a global life sciences company in reclassifying a domestic manufacturing site back into acceptable compliance status following a Form-483.
- Advised a domestic generic drug manufacturer with on-site inspection support and related regulatory meetings with FDA.
- Advised a drug manufacturer on issues related to application integrity.
- Advised multiple India-based generic drug manufacturers with on-site inspections and Form-483 and warning letter responses, including onsite support. Advice was focused on a range of issues including cleaning, data integrity, aseptic processing, computer systems, high-performance liquid chromatography, microbial contamination, and other manufacturer and testing-related issues.
- Advised laboratory developed tests (LDT) manufacturers on specific regulatory issues for their products as well as the FDA’s plan to transition away from the LDT enforcement policy.
- Advised a domestic food manufacturing facility with a microbiological contamination issue.
- Assisted with the submission of an Investigational New Drug (IND) application on behalf of the developer of a SARS-CoV-2 vaccine. Alston & Bird’s work included a protocol review, as well as advice regarding the delivery system for the vaccine and assistance addressing FDA questions regarding the application.
- Designed, directed manufacturing procedures, and ensured regulatory compliance of medical devices.
- Developed policies and standards for post-market regulation of laboratory-developed tests (LDTs), the manufacture of medical devices, submission review, inspection, and FDA enforcement.
- Assisted makers and importers of medical devices, pharmaceuticals, food, raw pet food, baby formula, and tobacco products in conducting recalls.
Benjamin K. Wolf
Partner,
- Phone: +1 202 239 3035
- Email: ben.wolf@alston.com
Ben advises clients regulated by the FDA on navigating complex regulatory risk across the product lifecycle, with a focus on medical and tobacco products. A former FDA regulatory counsel and medical device engineer, he helps clients anticipate and respond to FDA scrutiny, align regulatory strategy with business objectives, and manage enforcement, inspection, and compliance challenges.
- Aided pharmaceutical and medical device companies during FDA inspections and in responding to FDA inspectional observations and subsequent compliance and enforcement actions including warning letters and regulatory meetings.
- Advised clients marketing cannabidiol (CBD) and cannabis products on the legality of those products on a federal level and in label review, marketing, and business risk.
- Audited e-vapor clients for adherence to CGMP (also known as tobacco product manufacturing practices (TPMP)) and related regulatory requirements.
- Reviewed medical device, pharmaceutical, food, animal feed, dietary supplement, and tobacco labeling for regulatory compliance, claim substantiation, and litigation risk.
- Performed regulatory due diligence of medical device and pharmaceutical companies, including compounding pharmacies.
- Assessed appropriate regulatory pathways for medical devices and tobacco products.
- Reviewed compounded drugs formulations for permissibility to manufacture at a compounding pharmacy.
- Developed and submitted regulatory submissions for tobacco products which resulted in permitted marketing.
- Advised hearing aid manufacturers and distributors on matters related to hearing aid marketing, including OTC hearing aid requirements.
- Settled a civil money penalty (CMP) with the FDA resulting in a greater-than-95% reduction in the penalty amount.
Benjamin Wolf counsels clients in industries regulated by the Food and Drug Administration (FDA). Ben has particular interest and experience in medical devices, pharmaceutical drugs, agency compliance actions, inspection-related issues, biologics, and tobacco products, as well as the regulation of food, beverages, animal feed, dietary supplements, cosmetics, and cannabis.
While in his role in industry, Ben relied on his training as a biomedical and mechanical engineer to develop medical devices, assist with regulatory applications, and work to address regulators’ questions.
At the FDA, Ben reviewed product applications, conducted inspections, and developed policies for submission review, inspections, recalls, and other post-market issues with focuses on medical devices, combination products, and tobacco (including e-cigarettes).
In private practice, Ben has worked extensively in prominent FDA regulatory firms on matters involving medical devices, current good manufacturing practices (CGMP), pharmaceuticals, stem cells and human cell & tissue products (HCT/P), tobacco, food, animal feed, dietary supplements, cannabis, and cannabidiol (CBD) products. He is recognized by Best Lawyers: Ones to Watch® for Health Care Law.
Bar Admissions
- Virginia
- District of Columbia
Education
- The George Washington University (J.D., 2013)
- Columbia University (B.S., 2003)
Memberships
- American Bar Association
- Food and Drug Law Institute (FDLI), Medical Products Committee
- Olney Theatre Center, board of directors