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Drugmakers should implement and maintain security procedures for electronic safety-and-acknowledgement messages over the internet, according to a European draft guidance that provides technical requirements around online data protection. Read More
The FDA has warned another compounding pharmacy for actions that occurred prior to passage of a new federal law that boosted the agency’s authority over such facilities. Read More
Manufacturers should include effective evaluation and verification studies in their process validation documentation when obtaining biotechnology-derived proteins in the EU, according to a new guidance from the European Medicines Agency (EMA). Read More
The FDA has issued a warning letter to Mexican biologics maker Instituto Bioclon for “significant deviations” of current good manufacturing practices (cGMPs), including failures to ensure adequate environmental monitoring and employee training. Read More
One of the leading manufacturers of painkillers is calling for leniency from the Drug Enforcement Administration (DEA) if it decides to adopt new restrictions for hydrocodone combination products. Read More
Mylan and Actavis are challenging the FDA’s April 24 decision to grant 180-day marketing exclusivity to Teva for a generic version of the blockbuster arthritis drug Celebrex. Read More
The FDA on Monday approved UK-based NOVA Laboratories’ oral suspension drug for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination regimen. Read More
The European Medicines Agency (EMA) says the EU’s EudraVigilance database received more than 1 million post-marketing expedited adverse-drug-reaction (ADR) reports in 2013. Read More