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The European Medicines Agency entered the third phase of its plan to keep industry gears moving while the agency prepares for the UK’s exit from the EU, and said it will temporarily reduce or suspend more activities to save resources. Read More
The FDA issued draft guidance that outlines what the agency considers an ideal and robust verification system that’s also in line with legislative requirements. Read More
The FDA issued final guidance on “single-dose” and “multiple-dose” containers for injectable medical products — introducing a new term “single-patient use.” Read More
Drugmakers need to rethink the role of their quality departments, particularly when engaging with stakeholders and the broader company, says Marla Phillips, director of health initiatives at Xavier University, who previously served as head of quality at Merck’s North Carolina facility. Read More
On average, Missourians paid between 166 percent and 591 percent more than people in Italy, France and Canada for 65 percent of the 20 most commonly-prescribed brand name Part D drugs. Read More
Generic drugmakers Nexgen Pharma and Breckenridge Pharmaceutical argued that the market still needed a prescription version of the laxative so doctors could act as gatekeepers, citing increased hospitalizations and deaths in the wake of the OTC’s approval. Read More
Liver disease progression is an important endpoint, but assessing it can be challenging as the endpoints can occur infrequently until late in the course of chronic HBV progression. Read More
The FDA denied a petition from several pharmaceutical and outsourcing facilities urging the agency to keep implantable testosterone pellets off its Difficult to Compound list — but noted that so far it hasn’t made any moves to include it. Read More
The European Medicines Agency issued an updated action plan to encourage advanced therapy medicinal products (ATMPs) — including the release by year’s end of draft guidelines for clinical trial sponsors. Read More