Josephine M. Torrente

• Successfully appealed a Complete Response Letter that would have required additional adequate and well-controlled trials; obtained FDA approval with no new studies.
• Advocated for a biotechnology company before FDA to obtain 5-year Hatch-Waxman exclusivity for a complex mixture product whose components were already approved.
• Provided regulatory counsel to a brand name company in the first negotiation over single shared REMS with generic companies.
• Successfully argued to the FDA Chief Counsel’s Office that a class of combination products that were previouslyregulated as drugs should be considered biologics, following legislation on biologics exclusivity.
• Authored white paper arguing for accelerated approval in the face of pre-NDA comments from FDA indicating that thedrug was unlikely to be approved on existing data.
• Provided strategic advice to client teams preparing for successful Advisory Committee meetings for drugs in the oncology, metabolic diseases, and Central Nervous System (CNS) therapeutic areas.
• Led formal appeals of matters related to pre-approval CVOTs, pivotal trial enrichment strategies, magnitude of clinical benefit, validity of interim data, and imputation of missing data.

Tissue Products or HTC/P

• Counseled client regarding resolution of GMP/GTP issues in light of ongoing Phase 3 clinical trial.
• Submitted requests for designation of combination cell therapy products as medical devices or drugs.
• Assisted client in managing issues related to identity and potency assays for novel cellular therapy products.
• Provided regulatory counsel to major contract manufacturer of HCT/P therapies.

Corporate Transactions

• Led U.S. regulatory diligence for merger of companies with combined expected annual revenue of more than $475 million.
• Acted as lead FDA counsel representing issuers or underwriters for various IPOs and follow-on offerings.
• Routinely advises investor groups on risks and potential FDA actions based on publicly available information  for various drug and biological products.

• Best Lawyers, 2024, 2025
• Chambers and Partners, 2013-2019
• LMG Life Sciences
  2019 Regulatory Attorney of the Year, FDA Pharmaceuticals
  2023 Life Sciences Star

• More of a Bad Thing? Thoughts on FDA’s Proposal to Extend the FDR Process to Withdrawals of Accelerated ApprovalsApril 12, 2022

  By Michelle L. Butler & Josephine M. Torrente —

• What’s a Sponsor to Do?: The Curious Case of “Disputes” Over Phase 3 Study DesignJune 21, 2021

  By Josephine M. Torrente —

• Can’t Wait to See You! Will CDER Soon Resume In-Person Meetings?June 1, 2021

  By Deborah L. Livornese & Josephine M. Torrente —

• When FDA Makes You An Offer You Can’t RefuseMay 25, 2021

  By Deborah L. Livornese & David B. Clissold & Josephine M. Torrente —

• FDA Issues Draft Guidance Reflecting Expansion of PMR AuthorityNovember 21, 2019

  By McKenzie E. Cato & Josephine M. Torrente —