Ashish R. Talati is a Partner at Amin Talati. Mr. Talati primarily counsels companies and trade associations in the pharmaceutical and biotechnology industry on a wide range of issues surrounding U.S. Food and Drug Administration’s (FDA) review, approval, and oversight of drug and biological products. He counsels such drug and biotechnology clients as well as food, dietary supplement, cosmetic and medical device companies on matters of regulatory compliance, helps them anticipate and address regulatory issues in their day-to-day business operations and strategic planning, and advocates on their behalf before the FDA, FTC, Customs, USDA, DEA and other federal and state agencies, and in court.
Another strong practice area of Mr. Talati’s is helping to develop and enforce U.S. and International Intellectual Property rights such as Patents, Trademarks and Copyrights. Mr. Talati also assists clients with licensing, various types of contracts including supplier, manufacturing, distributor and franchise agreements, as well as business litigation in federal and state courts throughout the country. Most of Ashish’s litigation relates to FDA/FTC/State AG enforcement as well as to patent, trademark, copyright, false advertising, unfair competition and breach of contract litigation.
Education
J.D., St. John’s University School of Law
M.S., Biomedical Science, Drexel University
B.S., Biology, Loyola University of Chicago
Bar Admissions
New York
United States Patent and Trademark Office
U.S. District Court for the Northern District of Illinois
Professional Memberships
American Bar Association
New York State Bar Association
Drug Information Association
American Intellectual Property Association
Publications
A. Talati and A. Gurnani. "Dietary Supplement Adverse Event Reports: Review and Analysis." Food Drug Law J. 2009;64(3):503-13.
A. Talati and A. Gurnani. "The World's Most Trusted Article on Puffery" : Non-Actionable Puffery or Misleading? Food and Drug Law Institute. Update Magazine. Issue 6 (2008).
"New dietary ingredient notifications: a comprehensive review and strategies for avoiding FDA objections." Food Drug Law J. 2007;62(2):387-98.
"The Class Action Fairness Act of 2005: changing the class action landscape circuit by circuit." Food Drug Law J. 2006;61(3):561-8.
Webinars
Compliance Online:
"New dietary ingredient notifications: a comprehensive review and strategies for avoiding FDA objections."
"FDA Inspections-Dos & Don’ts."
"Responding to 483s and Warning Letters."
Speeches
The New Drug Approval Process: NDA Submission and Review. Introduction to Drug Law and Regulation: A Program on Understanding How the Government Regulates the Drug Industry. Food Drug and Law Institute. June 25-26, 2009. Washington D.C. USA.
Omega-3 Oils: How to Get FDA Approval. 4th Practical Short Course on Functional Oils: Omega-3 Fatty Acids -Market Trends, Nutrition & Health, Utilization in Food Systems. August 24-25, 2009. Chicago, IL USA.
Covering the Gray Area: What You Can and Can't Say on Your Labels. International Clinical Aromatherapy Conference and Wellness Expo. October 15-19, 2009. Chicago, IL USA.
Frankie Boyer Radio Health Show. Supply Side West. November 12, 2009. Las Vegas, NV USA.
Ashish R. Talati is a Partner at Amin Talati. Mr. Talati primarily counsels companies and trade associations in the pharmaceutical and biotechnology industry on a wide range of issues surrounding U.S. Food and Drug Administration’s (FDA) review, approval, and oversight of drug and biological products. He counsels such drug and biotechnology clients as well as food, dietary supplement, cosmetic and medical device companies on matters of regulatory compliance, helps them anticipate and address regulatory issues in their day-to-day business operations and strategic planning, and advocates on their behalf before the FDA, FTC, Customs, USDA, DEA and other federal and state agencies, and in court.
Another strong practice area of Mr. Talati’s is helping to develop and enforce U.S. and International Intellectual Property rights such as Patents, Trademarks and Copyrights. Mr. Talati also assists clients with licensing, various types of contracts including supplier, manufacturing, distributor and franchise agreements, as well as business litigation in federal and state courts throughout the country. Most of Ashish’s litigation relates to FDA/FTC/State AG enforcement as well as to patent, trademark, copyright, false advertising, unfair competition and breach of contract litigation.
Education
J.D., St. John’s University School of Law
M.S., Biomedical Science, Drexel University
B.S., Biology, Loyola University of Chicago
Bar Admissions
New York
United States Patent and Trademark Office
U.S. District Court for the Northern District of Illinois
Professional Memberships
American Bar Association
New York State Bar Association
Drug Information Association
American Intellectual Property Association
Publications
A. Talati and A. Gurnani. "Dietary Supplement Adverse Event Reports: Review and Analysis." Food Drug Law J. 2009;64(3):503-13.
A. Talati and A. Gurnani. "The World's Most Trusted Article on Puffery" : Non-Actionable Puffery or Misleading? Food and Drug Law Institute. Update Magazine. Issue 6 (2008).
"New dietary ingredient notifications: a comprehensive review and strategies for avoiding FDA objections." Food Drug Law J. 2007;62(2):387-98.
"The Class Action Fairness Act of 2005: changing the class action landscape circuit by circuit." Food Drug Law J. 2006;61(3):561-8.
Webinars
Compliance Online:
"New dietary ingredient notifications: a comprehensive review and strategies for avoiding FDA objections."
"FDA Inspections-Dos & Don’ts."
"Responding to 483s and Warning Letters."
Speeches
The New Drug Approval Process: NDA Submission and Review. Introduction to Drug Law and Regulation: A Program on Understanding How the Government Regulates the Drug Industry. Food Drug and Law Institute. June 25-26, 2009. Washington D.C. USA.
Omega-3 Oils: How to Get FDA Approval. 4th Practical Short Course on Functional Oils: Omega-3 Fatty Acids -Market Trends, Nutrition & Health, Utilization in Food Systems. August 24-25, 2009. Chicago, IL USA.
Covering the Gray Area: What You Can and Can't Say on Your Labels. International Clinical Aromatherapy Conference and Wellness Expo. October 15-19, 2009. Chicago, IL USA.
Frankie Boyer Radio Health Show. Supply Side West. November 12, 2009. Las Vegas, NV USA.