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Japanese regulators are weighing whether the agency will need to begin approving some drugs based on Phase II trial data as they implement approval processes for personalized drug products. Read More
Drugmakers should review their inspection standard operating procedures for producing off-site records and allowing FDA investigators to take photos or conduct interviews of employees, following new agency guidance on the topics. Read More
A proposed overhaul of FDA regulations would require the agency to update GMP regulations and guidances with modern manufacturing techniques. 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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Indian officials are accusing FDA investigators of inspecting drug manufacturers in the country without Indian inspectors present, violating an agreement between the two countries that calls for local regulators to tag along on FDA drug manufacturing inspections as observers. Read More