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A new chapter emerged this week in the contentious issue of patent thickets, a web of overlapping patents filed on a single existing product to create barriers to competition and extend effective patent life. Read More
In its first annual report, the CDER Office of Communications pointed to its three main goals, all of which focus on supporting the public’s faith in the FDA to protect public health. Read More
Many drug developers could improve the alignment of their quality units and their business units — and potentially avoid Form 483 inspection observations — if they dusted off and applied the International Council on Harmonization’s ICH Q10 Pharmaceutical Quality System guidance, according to one pharma quality expert. Read More
In a JAMA commentary on the research paper, scholars wrote that production problems are responsible for 70 percent or more of shortages on record. Read More
Following ample input and data provided by the FDA, HHS has issued a white paper detailing its progress in reducing what it labels a “decades-long public health issue” — drug shortages and supply chain vulnerabilities. Read More
Supernus Pharmaceuticals and IntelGenx have recently received Complete Response Letters (CRL) from the FDA requesting additional quality information on their drug-device combination products. Read More
The FDA’s Office of Pharmaceutical Quality (OPQ) finished out 2023 by progressing in all four of its strategic priorities: collaboration, communication, engagement, and innovation, according to its 2023 annual report. Read More
U.S. drugs in shortage have reached “record highs” and policymakers must address gaps in pharmaceutical supply chains to better prepare for future, unanticipated shocks, according to researchers from University of Pittsburgh School of Medicine. Read More