fbpx
December 21, 2022

M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol

Docket Number: FDA-2022-D-3054 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy The purpose of this document is to serve […]
December 21, 2022

Controlled Correspondence Related to Generic Drug Development

Docket Number: FDA-2014-D-1167 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy This guidance provides information regarding the process by […]
December 20, 2022

Health Fraud Scams

Advisory Letters The U.S. FDA issued letters to these companies for illegally marketing products for the treatment or prevention of serious diseases. Thirty days after FDA […]
December 20, 2022

Office of Digital Transformation’s New Focus on Technology Leadership

Image By: Vid Desai, Chief Information Officer and Jessica N. Berrellez, Executive Officer Vid Desai Digital transformation is a continuous journey that touches every part of […]
December 20, 2022

Sagent Pharmaceuticals, Inc. – 636636 – 07/27/2022

Delivery Method: Via Email Delivery Confirmation Product: Drugs Recipient: Recipient Name Dr. Peter A. Kaemmerer Recipient Title Chief Executive Officer Sagent Pharmaceuticals, Inc. SterRx, LLC 1901 […]
December 20, 2022

Adarsh Daswani, M.D. – 648606 – 12/14/2022

Delivery Method: VIA UNITED PARCEL SERVICE Product: Drugs Recipient: Adarsh Daswani, M.D. 5471 La Palma Avenue, Suite 203La Palma, CA 90623United States Issuing Office: Center for […]
December 20, 2022

DuPont Nutrition USA Inc. – 627211 – 12/02/2022

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Mr. Matthew Davidson Recipient Title Plant Manager DuPont Nutrition USA Inc. 1301 Ogletown Rd Newark, DE 19711United […]
December 20, 2022

CHS Inc./CHS River Plains – 642790 – 11/30/2022

Delivery Method: VIA UPS Product: Animal & VeterinaryDrugs Recipient: Recipient Name Jay Debertin Recipient Title President and CEO CHS Inc./CHS River Plains 5500 Cenex DriveInver Grove […]
December 20, 2022

Nortec Quimica SA – 639894 – 12/08/2022

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Marcelo C. Mansur Recipient Title CEO and President Nortec Quimica SA Rua Dezessete, 200, Distrito IndustrialXeremDuque […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0