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FDA officials sought to clarify how the agency’s authority to punish drugmakers for obstructing facility inspections applies to such issues as divulging trade secrets, accessing emails and translating documents into English. Read More
Australia’s pharmaceutical regulatory body has adopted European guidance on good pharmacovigilance practices for vaccines, including the reporting of reduced effectiveness or vaccine failure, and implementing a recall or halting distribution of batches. Read More
The European Commission has approved a new indication for Roche’s rheumatoid arthritis drug RoActemra to treat patients in the early phase of the disease. Read More
Connecticut’s Attorney General has joined a growing chorus of voices urging the FDA to immediately approve a generic version of AstraZeneca’s acid-reflux drug Nexium, either by clearing first-filer Ranbaxy’s version or by finding that the Indian firm forfeited its exclusivity because of rampant delays. Read More
The head of a non-profit that pushes for more products to be made in the U.S. is suing Apotex and Costco for selling a generic of the cholesterol drug Lipitor that didn’t indicate it was made in India. Read More
New Jersey-based compounder Pharmacy Creations is recalling one lot each of four products after a former testing laboratory found that the lots in question may not be sterile. Read More
A federal judge last week affirmed the FDA’s decision to approve generic versions of Hospira’s sedative Precedex under a pathway that allows manufacturers Mylan and Par to proceed with generics that “carve out” the brand firm’s method-of-use patent in the drug’s labeling. Read More
CDER Director Janet Woodcock is calling on industry to collaborate in the development and verification of new biomarkers, which the agency says can improve clinical trial efficiency but so far have been underused. Read More