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The FDA has upgraded the status of Hospira’s troubled Rocky Mount, N.C., manufacturing plant to allow it to begin using the facility to manufacture new products. Read More
The FDA and Indian Ministry of Health & Family Welfare will begin sharing information from quality inspections of drugmakers’ manufacturing facilities. Read More
The HHS Office of Inspector General (OIG) this year plans to analyze the findings from FDA inspections of generic drugmakers’ facilities to determine the effectiveness of inspections on ensuring the quality of generic medicines. Read More
Just when things were starting to turn around for Teva, the Israeli drugmaker said Monday it was under federal investigation for potential marketing violations of its drugs Copaxone and Azilect. Read More
Unresolved investigations into bottling and packaging operations and insect problems have landed one of Sandoz’s U.S. facilities a Form 483. During an October inspection of Sandoz’s Broomfield, Colo., facility, investigators found spiders, centipedes and moths. Read More
The HHS Office of Inspector General (OIG) this year plans to analyze the findings from FDA inspections of generic drugmakers’ facilities to determine the effectiveness of inspections on ensuring the quality of generic medicines. Read More
The FDA will create a pharma-only enforcement unit that promises more consistent inspections and enforcement decisions with fewer bureaucratic hurdles for investigators to issue warning letters. Read More
Beginning in June, drugmakers selling in the EU must notify the European Medicines Agency (EMA) of any unreported changes or updates to product marketing authorizations in any member states and must complete that update on all products by December. Read More
The compounding pharmacy lobby is pushing back against the FDA’s campaign to encourage hospitals to buy compounded drugs only from agency-registered sites as disingenuous and misleading, saying the products aren’t necessarily safer for patients. Read More