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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
Drug recalls increased for the third straight year, with companies pulling 4 percent more products in 2014 than the previous year and foreign particles being the top culprit. Read More
The FDA has upgraded its rating on Fresenius’ APP Pharmaceuticals’ New York plant, clearing the facility, which had been troubled by pest problems, to produce new drugs for Fresenius’ Kabi arm. Read More
The FDA warned that counterfeit versions of Eli Lilly’s popular erectile dysfunction drug Cialis were found in the mail to a U.S. customer — marking the first major counterfeit incident of 2015. Read More
In a 46-page draft guidance released last month, the FDA clarified a 2013 final rule that specifies how combination product manufacturers should meet both device and drug quality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
Beginning last month, all NDAs will undergo a risk assessment by a team of FDA reviewers that will follow the drug from preapproval through manufacturing and into any eventual generic forms in an effort to ensure quality throughout a product’s lifecycle. Read More