Simplifying Global Compliance
The European Medicines Agency published a reflection paper on assessing the frailty of elderly patients in clinical trials, recommending the Short Physical Performance Battery assessment for its prognostic value and ease of use. Read More
The EMA’s Committee for Medicinal Products for Human Use recommended five medicines for European Commission approval and six extended indications at its meeting this month. Read More
A former Horizon Pharma senior director sued the drugmaker, claiming she was fired for raising concerns about off-label drug promotion at a previous employer. Read More
The FDA finalized a Q&A guidance clarifying the International Council for Harmonization’s November 2012 Q11 guidance on development and manufacture of drug substances — giving recommendations for information that should be provided in authorization applications for starting materials. Read More
The FDA slapped TrueCare Biomedix with a Form 483 for numerous procedural issues and violations observed during a November inspection of its facility in Gujarat, India. Read More
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