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The European Medicines Agency (EMA) is recommending clinical trial sponsors evaluate local tolerance of medicinal products — i.e., both the active substance and excipient — at contact sites of the body as part of a clinical trial’s general toxicity studies, according to new draft guidance. Read More
Pfizer is receiving blowback from UK scientists, lawmakers and a top company executive for its proposed multi-billion dollar merger with London-based AstraZeneca (AZ). Read More
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security procedures for electronic safety-and-acknowledgement messages over the internet, according to a European draft guidance that provides technical requirements around online data protection.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