clinicaltrialsarena8d
FDA protocol deviation guidance could go further
The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.
The Statesman14d
135 drug samples identified as not of standard quality
The Central Drugs Laboratories identified 51 drug samples to be not of standard quality (NSQ), while State Drugs Testing Laboratories also found 84 drugs samples not of standard quality during the ...
Benzinga.com16d
Sanofi Genzyme Facility Draws FDA Criticism Over Alleged Quality Lapses
20% of bioreactor runs at the Genzyme facility failed due to contamination or quality issues over 2.5 years. FDA identified 84 overdue deviation investigations, some exceeding 180 days ...
Nasdaq17d
Glucotrack, Inc. Achieves ISO 13485:2016 Certification, Enhancing Commitment to Quality in Diabetes Technology
The ISO 13485 standard is essential for ensuring the safety and effectiveness of medical devices and aligns with the recent U.S. FDA Quality Management System Regulation that harmonizes U.S. and ...
中国日报网17d
Officials to gather feedback on drug quality
The administration said a team including officials from health, industry, information technology and drug regulation agencies will visit Shanghai on Tuesday to collect suggestions on the procurement ...
Forbes22d
FDA’s Red Dye No. 3 Ban, Explained—What It Means For Food And Trust
Red Dye No. 3, or erythrosine, is a synthetic red food dye once popular in candies and cakes. The ... [+] FDA bans Red Dye No. 3 under the Delaney Clause, citing cancer risks observed in lab ...
Time23d
FDA Bans Red Dye No. 3 From Foods
Food and Drug Administration officials granted a 2022 petition filed by two dozen food safety and health advocates, who urged the agency to revoke authorization for the substance that gives some ...
PBS23d
FDA bans red dye No. 3 from foods, nearly 35 years after it was barred from cosmetics because of potential cancer risk
Food and Drug Administration officials granted a 2022 petition filed by two dozen food safety and health advocates, who urged the agency to revoke authorization for the substance that gives some ...
HuffPost23d
FDA Bans Red 3 Dye From The Nation’s Food Supply
Food and Drug Administration officials granted a 2022 petition filed by two dozen food safety and health advocates, who urged the agency to revoke authorization for the substance that gives some ...
News Medical24d
Market Report 2025: Pharmaceutical Manufacturing
During drug development, AI has been used to ... regulatory compliance include the implementation of a strong quality management system (QMS), proactive audits and inspections, regular training ...
Food Processing24d
FDA Unveils its Proposed Front-of-Package Labeling System
Called the Nutrition Info box, it would detail the relative amounts of three nutrients—saturated fat, sodium and added sugars—in a serving of food and would appear on the package’s front. The FDA ...