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The FDA has issued a warning letter to Mexican biologics maker Instituto Bioclon for significant GMP deviations including failures to ensure adequate environmental monitoring and employee training.
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British authorities continue to investigate 21 cases of blood poisoning in babies who received potentially contaminated batches of an intravenous liquid feed at neonatal intensive care units in England, but said the manufacturer of the product was following good manufacturing practice guidelines. Read More
Unsanitary lab coats, hairnets and facemasks were among the problems cited in a warning letter to compounding pharmacy Medaus, the latest compounder to receive a warning from the FDA. Read More
A federal appeals court needs to rethink its definition of “a patient” or risk upholding a dangerous precedent in future Hatch-Waxman cases after a recent patent ruling on the colon cleanser Suprep, trade groups BIO and PhRMA argue in a joint legal brief. Read More
A Massachusetts insurer filed a lawsuit this week against Takeda and Eli Lilly in the U.S. District Court for the Western District of Louisiana for allegedly hiding cancer risks of its type 2 diabetes drug Actos. Read More
The FDA for the first time has consolidated all elements that generic manufacturers must include in their ANDAs in an effort to increase the success rate of new submissions. Read More
A European pharmaceutical trade group has blasted a decision by Italian regulators that would allow the government to pay for an off-label eye treatment, saying the decision was motivated by cost savings and could undermine EU’s regulatory authority. Read More
Faulty lab coats, hairnets and facemasks were among the problems cited in a warning letter to compounding pharmacy Medaus, the latest compounder to receive a warning from the FDA. Read More
The European Medicines Agency is streamlining the declarations that Qualified Persons must file to assure the agency that makers of active substances are compliant with good manufacturing practices. Read More