Erich Drotleff is a seasoned and business-oriented corporate generalist attorney who excels at gaining the confidence and trust of business partners and executive leadership teams to efficiently achieve business objectives. Strong management and communication skills. Proven ability to deliver practical solutions under pressure in a fast-paced environment. Areas of expertise include telemedicine, digital healthcare, technology, data privacy, compliance, contract negotiation, supply chain, and commercial disputes. He is a California-licensed attorney and New York registered in-house counsel.

https://www.linkedin.com/in/erich-drotleff-jd-mph-95aab18/

Nathan A. Beaver is a seasoned FDA attorney known for responsive, big-picture advice. He counsels food and drug manufacturers, distributors, and retailers as they navigate federal and state agency compliance and regulatory issues. Whether clients are looking to move products through the FDA approval process, dealing with advertising or regulatory compliance issues, concerned with regulations related to telemedicine, involved in an M&A transaction, or facing FDA emergencies such as product recalls or inspections, Nate utilizes his deep understanding of the food and drug industry to help clients meet their long-term objectives.

A partner and food and drug lawyer with Foley & Lardner LLP, Nate’s practice focuses on the representation of companies whose products and activities are regulated by the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), U.S. Department of Agriculture (USDA) and Federal Trade Commission (FTC). He advises clients on regulatory issues affecting prescription and over-the-counter drug products (including animal drugs), medical devices, dietary supplements, cosmetics and foods. Nate also has significant experience in FDA compliance and enforcement issues including 483s, warning letters and consent decrees.

Nate’s FDA regulatory and compliance experience is valuable to health care and life sciences companies involved in mergers and acquisitions. He regularly advises clients in M&A transactions and IPOs, including due diligence and diligence assessments, negotiations of regulatory issues in asset and purchase agreements, including reps and warranties, and post-transaction licensure issues.

Nate counsels’ telemedicine and digital health companies on federal and state laws governing the prescription of controlled substances via telemedicine. He has advised on state medical and controlled substance licensure, federal DEA controlled substance registrations, as well as requirements to create a valid prescriber-patient relationship. Nate has represented companies in the digital health space in complying with FDA requirements and determining when FDA jurisdiction is not present.

Nate also advises clients on the marketing of industrial hemp and CBD in food and beverage products as well as other FDA regulated products including cosmetics. Nate has advised retailers, manufacturers, and universities on compliance with the 2018 and 2014 Farm Bills relating to industrial hemp as well as state requirements for marketing hemp and CBD.

Co-chair of the firm’s Food & Beverage Industry Team and its Health Care & Life Sciences Sector – Medical Devices, Nate is a member of Foley’s Government Solutions and FDA Practices and its Cannabis Industry Team.

With backgrounds in pharmacy and law, and 14 years of regulatory experience at the Food and Drug Administration (FDA), clients rely on David Rosen’s nearly five decades of knowledge when seeking strategic guidance on FDA submissions, compliance, advertising, and enforcement.

A partner and public policy lawyer with Foley & Lardner LLP in the firm’s Washington, D.C. office, David has extensive experience in health law, life sciences, and food and drug regulation, including a range of FDA regulatory issues affecting prescription and over-the-counter pharmaceuticals, medical devices, and biologics. He is the firm’s FDA Practice Group leader, and member of the Government Solutions Practice Group, the Cannabis and Food & Beverage Industries, and the Health Care & Life Sciences and Telemedicine Sectors.

At FDA, David progressed to various supervisory positions involving virtually all aspects related to the drug approval process, combination products, jurisdictional issues, and related compliance activities. He authored the FDA’s Orange Book (Approved Drug Products With Therapeutic Equivalence Evaluations), which identifies drug products approved by FDA on the basis of safety and effectiveness under the Federal Food, Drug, and Cosmetic Act; and was instrumental to the development and implementation of the Hatch-Waxman Act (the Drug Price Competition and Patent Term Restoration Act), as well as FDA’s Accelerated Approval regulations for new drugs. He utilizes this insider perspective to assist clients within all FDA-regulated industries respond to warning letters and FDA 483 observations, write FDA meeting requests for pre-IND and 505(b)(2) products, and interact with FDA to facilitate product review and approval. He is a recognized leader in virtually all aspects related to the drug and medical device approval/clearance processes, combination products, and jurisdictional issues.

David frequently speaks before national and international pharmaceutical industry associations on the ANDA submission and review process and on the IND and expedited drug development, review, and approval processes. He has presented before investment analysts and managers of venture capital on the impact of FDA on the drug and biotech industry.

David was formerly a partner at two other major law firms where he was a member and leader of the FDA and life sciences practices.