The Generic Drug Cluster is a consortium of top regulatory agencies from around the world that get together to discuss common issues related to the drug approval process in an effort to better understand how each agency approaches various topics. Hopefully, these discussions will result in developing regulatory strategies that reflect the best and most […]
For certain “companies that first registered with the FDA during the COVID-19 public health emergency (PHE) solely for purposes of manufacturing OTC hand sanitizer products during the PHE were not identified as facilities subject to the OMUFA facility fee, for a certain time period. That time period, which extended beyond the end of the PHE, […]
For those of you who follow the daily approvals page (here), on November 21, 2024, there was a flurry of supplemental labeling approvals listed for drug products that contain non-steroidal anti-inflammatory drugs (NSAIDs), from aspirin to Zipsor (diclofenac potassium). In today’s CDER Drug Safety-related Labeling Changes (SrLC), the new, revised warning that must be included was […]
Today’s Federal Register pre-publication page contains a notice that is likely the final punch before the oral decongestant phenylephrine lies knocked out on the canvas. The notice (here) states in regard to the “proposed revision of the proposed order OTC000036 to amend the requirements for cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter […]
Baxter Recovery and FDA Actions The FDA announced additional actions “to increase access to and supply of IV and peritoneal dialysis (PD) solutions following Hurricane Helene-related damage to Baxter International Inc.’s North Cove facility in Marion, North Carolina.” The FDA performed assessments to enable import of IV solutions and PD solutions from seven different Baxter […]
It was just last week, on October 7, 2024, when we published a blog (here) titled FDA Planned OTC Monograph Actions. That post outlined the OTC monograph issues that the Agency was planning to address over the next three years. Well, obviously, the FDA must have had its eyes set on beginning efforts on the issue […]
U.S. and EU efforts to manage supply chain shortages are slowly converging; however, the political winds in the Rest of World (ROW) may be diluting required oversight. Both the U.S. (Risk Management Plans to Mitigate the Potential for Drug Shortages | FDA) and EU (Shortage Prevention Plan (SPP) – template (europa.eu)) have published either a […]
Each year, the Office of Pharmaceutical Quality (OPQ) releases a report on the state of pharmaceutical quality. This year’s report was released yesterday and can be found here. Every year we try to pick out key issues and highlight some of the statistics outlined in the report, and this year is no different! Some important […]
This morning, the FDA published a reminder (here) that over-the-counter (OTC) monograph user fees (OMUFA) for facilities must be paid today, noting that it “is in reference to the March 29, 2024, Food and Drug Administration Federal Register notice (FRN) titled ‘Over-the-Counter Monograph Drug User Fee Program-Facility Fee Rates for Fiscal Year 2024.’ The fiscal year […]
It’s fascinating to see the evolution and potential future of visual inspection in the pharmaceutical industry. The shift from manual methods to cutting-edge automated systems with artificial intelligence has significantly improved efficiency, accuracy, and reliability in product inspections. By leveraging AI technology in visual inspections, pharmaceutical companies can benefit from enhanced defect detection capabilities, greater […]
