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The FDA’s proposed new labeling requirements for generics pose such a challenge to industry that GPhA has asked the FDA for an additional two months to comment on the proposed rule. Read More
Baxter has issued another recall, this time for a single lot of the nitroglycerin 5 percent dextrose injection, a drug used for pre- and post-operative hypertension, congestive heart failure at the onset of heart attack and chest pain. Read More
Tamper-evident packaging and registered product trademarks are two features Johnson & Johnson (J&J) employs to minimize a product’s risk of being counterfeited or diverted. Read More
Alexion’s recall and replacement of vials of its rare disease drug Soliris could cost the company between $10 and $25 million in the fourth quarter, the drugmaker says in an SEC filing last month. Read More
More than three years after Hospira’s Rocky Mount, N.C., plant was warned for lax quality control, prompting a painful manufacturing slowdown and a costly remediation, the drugmaker expects to near the “top end” of production capability in 2014, Hospira’s chief said last month. Read More
Congress rejected the FDA’s call for mandatory oversight of compounding pharmacies, passing legislation that instead allows compounders to volunteer for agency oversight. Read More
Drugmakers have 13 months to revamp how they track drugs after President Barack Obama signed into law a measure that would establish a nationwide track-and-trace requirement for prescription drugs. Read More
UK-based Egalet has signed a licensing agreement with Shionogi to develop and market oral abuse-deterrent hydrocodone opioid products, with Shionogi footing the bill for all development costs and holding on to global marketing rights. Read More
Tamper-evident packaging and registered product trademarks are two features Johnson & Johnson (J&J) employs to minimize a product’s risk of being counterfeited or diverted. Read More
The FDA Tuesday hit Wockhardt with a second “import alert,” banning drug products from its Chikalthana plant in western India — the latest in a spate of regulatory actions taken against the struggling drugmaker. Read More
The Generic Drug User Fee Amendments of 2012 do not allow for a waiver, reduction nor postponement of finished dosage form (FDF) facility fees for small and/or foreign businesses, the FDA says in a letter denying Square Pharmaceuticals’ citizen petition requesting a waiver and change to GDUFA’s statutory language. Read More