Procter & Gamble (NYSE:PG) recently received a warning letter from FDA for failing to meet the agency’s requirements in the drug listing. The warning related to Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion (National Drug Code (NDC): 58933-541), a powdered medicine intended to be dissolved in hot water before use. The FDA’s…

The state of California has established a $50 million collaboration over a decade with the generic drug manufacturer Civica. The goal of the collaboration is to create affordable state-branded generic insulin. Qualified individuals may obtain a 10-mL vial of generic insulin for $30 or less. California plans to provide a pack containing five prefilled 3…

The FDA recently published guidance to help the pharma industry detect suspicious and illegitimate products within the pharmaceutical supply chain. These regulations, established under the Drug Supply Chain Security Act (DSCSA), concentrate on product tracing, verification, and identification for specific drug products distributed in the U.S. So far this year, the agency has released more than…

PRISM.science, a biomedical database company, has launched a new product called AE Alert. The adverse event detection product provides comprehensive global literature surveillance to monitor adverse events related to prescription drugs. This product is designed to address the limitations of conventional pharmacovigilance literature surveillance by aggregating content in real-time. The company says AE Alert has…

In the first half of February, the FDA posted to its website several warning letters to companies and facilities for violations of cGMP regulations. The agency’s Center for Drug Evaluation and Research and Division of Pharmaceutical Quality Operations divisions sent warning letters to two hand sanitizer companies, a Turkish drug manufacturer, a Palm Beach Fertility…

The software company Model N (NYSE:MODN) has released its fifth annual State of Revenue report that found many pharma companies are grappling with staffing and economic challenges. In particular, 92% of pharmaceutical firms reported difficulties hiring qualified personnel. A number of pharma companies are cutting staff this year. Almost half, 47%, of pharma execs believed…

The omnibus spending bill recently signed by President Joe Biden directs the FDA to expand unannounced foreign facility inspections and evaluate them through a new pilot program. The legislation includes $10 million for the program and a mandate to increase unannounced surveillance inspections of foreign drug establishments, Regulatory Focus reports. The legislation also directs the…

Fresenius Kabi has begun selling gadoterate meglumine injection, USP, a bioequivalent and therapeutic equivalent substitute for Guerbet’s contrast agent Dotarem. The product launch is the second contrast agent Fresenius Kabi has introduced in the U.S. this year. The Kale Zurich, Illinois–based company launched iodixanol injection, USP, in July during a nationwide shortage. Radiologists use contrast agents…

In Q2 2022, the number of recalled units in the U.S. pharma industry dropped sharply. In the first quarter of the year, drug makers recalled more than 435 million units. However, the number of recalled units in Q2 2022 was 20.5 million, according to the Sedgwick Brand Protection Q2 2022 recall index. “It was definitely a…

The FDA continues to pressure manufacturers and distributors for selling products with undeclared sildenafil and tadalafil. The agency recently announced that Wilmington Delaware–based Ultra Supplement LLC is voluntarily recalling lot number DAP272109 of Sustango capsules over the presence of tadalafil (Cialis). The company markets the product as a supplement for men. Sustango was available for…