Faraz Rahim Siddiqui Associate

Overview

Faraz Siddiqui advises clients in the food and life sciences industries on a wide range of FDA-regulatory matters, including issues related to regulatory and expedited pathways, pharmacovigilance, safety reporting, marketing and promotion, registration and listing, labeling and promotion, and state licensure. He has also conducted due diligence for buyers in large merger and acquisition transactions, and supported other clients in litigation stemming from such transactions.

Prior to his legal career, Mr. Siddiqui founded Global Inroad Consulting, a management consulting firm based in Canada, where he advised international clients on organizational strategy and communication. Faraz also worked at the O’Neill Institute of National and Global Health Law at Georgetown Law School, conducting public health policy research for the European Commission.

As a law student, Faraz interned with an administrative appeals judge at the U.S. Department of Health & Human Services, a judge at the District of Columbia Superior Court, and with the judges of the World Bank Administrative Tribunal, an independent judicial forum of last resort for staff of the World Bank.

Mr. Siddiqui holds a Masters in Public Health from Johns Hopkins Bloomberg School of Public Health and worked as an epidemiologist for Baltimore City. He focused on quantitative research skills and risk communication and policy. He uses his background to better advise clients on the FDA approval practices and provide a multidisciplinary approach to client advocacy. He has published articles in the intersection of health law, policy, and public health.

Education & Admissions

Education

J.D., Howard University School of Law, magna cum laude
M.P.H, Johns Hopkins Bloomberg School of Public Health
B.S., University of Toronto, with Honours

Admissions

American Bar Association
District of Columbia
U.S. District Court of District of Columbia

Experience

  • Provided practical and strategic FDA regulatory advice to a broad spectrum of corporate clients on initiatives or activities involving FDA-regulated products and options and strategies to navigate regulatory hurdles to advance their business needs while addressing their legal risks and protecting the company’s integrity;
  • Focused on drugs, biologics, medical devices, food, and tobacco products in all phases of the product lifecycle; experience in pharmacovigilance, state licensure, data integrity, cell and gene therapies, expedited pathways, packaging and labeling, regulatory submission standards, promotion, establishment registration and listing, and DSCSA
  • Supported litigation counsel in Delaware Chancery Court lawsuits challenging mergers for issues related to data integrity, GxP compliance, Application Integrity Policy and fraud; supported e-discovery and creating legal strategy including in the landmark Fresenius v. Akorn case; helped draft a cease & desist letter on claims made by client’s competitor that were not supported by scientific evidence
  • Conducted due diligence of transactions in the life sciences industry by characterizing legal and business risk, negotiating key regulatory terms to manage such risks, and supporting post-transaction integration activities; led diligence calls and drafted diligence memoranda summarizing risks related to clinical trials, manufacturing, company policies, promotional materials and product authorizations; also summarized legal risks in SEC filings
  • Drafted comments and white papers to advocate for client interests; often used FDA approval and enforcement databases to understand FDA practice and leverage that for client’s arguments; interpret statutes, regulations, and FDA guidance to better characterize client needs and answer client questions
  • Non-FDA matters include reviewing a value-based employer health plan contract; drafting a comment on CMS pricing regulation; filing a FOIA complaint in Federal District Court of DC to compel production; representing a central American family in affirmative and defensive asylum proceedings

Honors & Awards

Vincent F. Prada Pro Bono Award 2018, 2019

Education

J.D., Howard University School of Law, magna cum laude
M.P.H, Johns Hopkins Bloomberg School of Public Health
B.S., University of Toronto, with Honours

Admissions

American Bar Association
District of Columbia
U.S. District Court of District of Columbia

Practice Areas
Industries
FDA Regulatory Categories