Drug GMP Report

Despite the COVID-19 pandemic making manufacturing site inspections difficult in 2020, the FDA’s Center for Drug Evaluation and Research (CDER) met most of its drug and biologic review goals last year, but — as it warned it would — the agency struggled to meet its inspection goals. Source: Drug GMP Report

FDA has published two guidances focused on maintaining compliance with the agency’s mislabeling regulations as well as how best to name new drugs so that consumers can avoid medication errors. Source: Drug GMP Report

FDA inspections revealed good manufacturing practice and other deficiencies at drug manufacturing facilities in New Jersey, Vermont and California, leading to Form 483 inspection observations for four firms. Source: Drug GMP Report

A final guidance published Dec. 17 indicates the FDA will limit the kinds of questions generic drug sponsors may submit to the agency to get feedback during drug development. Source: Drug GMP Report

A Florida manufacturer of over-the-counter drug products had high microbial counts in water it used for manufacturing among other significant violations of current good manufacturing practice, according to an FDA warning letter to the firm. Source: Drug GMP Report

Warnings of international crime targeting the yet-to-be-approved COVID-19 vaccines are getting louder, with the international police agency Interpol issuing an Orange Notice, which warns of an “imminent threat to public safety.” Source: Drug GMP Report

By the end of 2022, drug, device and biologic product sponsors that are required to submit a risk evaluation and mitigation strategy (REMS) will have to do so electronically, the FDA said in a final guidance issued late last month. Source: Drug GMP Report

The FDA is working on a report tied to a two-day meeting held in December to discuss its pilot program on pharmaceutical supply chain interoperability, as well as other efforts to modernize the drug supply chain in the U.S. Source: Drug GMP Report

The FDA issued a complete response letter (CRL) to Sanofi for sutimlimab, an investigational monoclonal antibody for treating hemolysis in adults with the rare autoimmune condition, cold agglutinin disease. Source: Drug GMP Report

Hacker groups in Russia and North Korea continue to mount cyberattacks against companies working on COVID-19 vaccines and treatments, Microsoft warned, calling on governments to take action against them. Source: Drug GMP Report