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A suggested link between Novartis’ heart failure drug LCZ696 and progression of Alzheimer’s disease could sour hopes of a pipeline replacement for the company’s failed Reasanz heart drug. Read More
The FDA barred beleaguered drugmaker Ipca Laboratories from shipping drugs to the U.S because of good manufacturing practice violations — the 27th time the agency has cracked down on GMP violations at Indian drug facilities in the last two years. Read More
In a 46-page draft guidance, the FDA clarified a 2013 final rule that specifies how combination product manufacturers should meet both device and drug quality regulations and implement streamlined quality systems. Read More
UK regulators shut down a plant in Cambridgeshire that was producing an unapproved and unlicensed product used against diseases such as HIV and cancer. Read More
The FDA warned an Indian manufacturer to immediately stop ignoring poor test results, the second Indian facility in a week to get a warning letter for data integrity violations. Read More
The number of new drug shortages in 2014 remained at 44 for the second year in a row, with the FDA making full use of new tools to prevent shortages that reached a critical mass three years ago at 251. Read More
With the FDA stepping up scrutiny of data integrity during facility inspections, drugmakers must be ready to answer tough questions about their electronic record system, an inspections expert said. Read More
Most drugmakers bend over backwards to comply with GMPs by setting up reliable quality systems and going by the book. But they still get chided by the FDA for poor quality goods produced outside their facility, one expert says. Read More
Luitpold Pharmaceuticals was chided by the FDA for failing to properly investigate how severe roof leaks in 2013 and 2014 affected production. Read More
Contract OTC manufacturer Gopers Int. doesn’t have a quality control unit, keep batch records or properly train its employees, according to an FDA Form 483 that features a litany of quality violations. Read More
Ariad Pharmaceuticals failed to submit a slew of adverse event reports within the 15-day deadline and follow the risk evaluation and mitigation strategy for its blockbuster leukemia drug Iclusig, prompting a 483.
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