The Food and Drug Administration revealed that Kingen Biotech Co., Ltd. still lacks important information. Expedited delivery for the 3rd time
On June 15, 2021, reporters reported that Mr. Paisan Dankum, secretary-general of the Food and Drug Administration, revealed that according to Kingen Biotech Co., Ltd. pgslot has submitted a document for permission for the Sputnik V vaccine with the Food and Drug Administration. Drug (FDA) that
Currently, the FDA has received the latest information on June 9, 2021, which the FDA has examined and found that the latest information submitted is the same set of information that was previously filed with the FDA. Safety, quality and evidence of manufacturing standards GMP PIC/S or equivalent
For the lack of data, 50 percent of the data used for consideration, such as detailed information about important drugs. Detailed analytical methods of active drugs and pharmaceutical products Product Safety Information
In this regard, the FDA has informed Kingen Biotech Co., Ltd. to deliver important information used for urgent consideration for the third time.
Reporters reported that earlier (May 6), Dr. Surachoke Tangwiwat, Deputy Secretary-General of the Food and Drug Administration revealed that he had informed Kingen Biotech Co., Ltd. to send important information in several parts, including the production process. and quality control of vaccines Vaccine Safety and Effectiveness Vaccine Risk Management Plan Good Manufacturing Practices (GMP) Vaccines by May