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European regulators are looking to industry for suggestions on the best ways to get generic versions of topical drugs approved without having to conduct time-consuming and expensive clinical trials to prove bioequivalence. Read More
Reckitt Benckiser is voluntarily recalling 1.5 million units of four varieties of its Mucinex liquid cold medicines nationwide because the back labels may not show they contain acetaminophen and other active ingredients. Read More
The FDA’s Office of Pharmaceutical Quality is developing a new inspection protocol that will focus on expert investigator-developed questions and assessment practices. Read More
The European Medicines Agency is tightening its rules around conflicts of interest, barring individuals who take jobs in industry from serving on any of its advisory committees. Read More
The International Society for Pharmaceutical Engineering is developing a tool to help manufacturers locate gaps in production and quality systems, with the aim of averting shortages in the international drug supply. Read More
Particulates have forced yet another drugmaker — this time Teva — to recall an injectable. The drugmaker voluntarily recalled eight lots of its anticancer therapy Adrucil after a combination of silicone rubber from a filling diaphragm and fluorouracil crystals was found in vials. Read More
The FDA should issue guidance officially adopting U.S. Pharmacopeia standards in its visual particle inspections of injectable drugs, law firm Hogan Lovells says in an April 13 citizen petition submitted to the agency on behalf of an unnamed drugmaker. Read More
Reckitt Benckiser is voluntarily recalling 1.5 million units of four varieties of its Mucinex liquid cold medicines nationwide because the back labels may not show they contain acetaminophen and other active ingredients. Read More
Beleaguered Indian generics maker Wockhardt said Tuesday it will recall all remaining batches of 12 to 15 products from the U.S. that were manufactured at its Waluj and Chikalthana, India, plants, due to quality concerns. Read More
Particulates continue to be a major cause of recalled injectables, with Mylan late last month recalling eight lots of four drugs after foreign matter was found during quality control tests. Read More
Baxter International has issued its sixth recall of intravenous solutions since December 2013, recalling 15 lots — about 237,000 units — because they may contain particulate matter. Read More