Drugindustrydaily

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Feb. 26, 2018

Vol. 17
No. 38

Headlines

EMA Recommends Short Physical Performance Battery for Assessing Frailty

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

CHMP Recommends Five Drugs, Including First Medicine for Neonatal Diabetes

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

Ex-Horizon Exec Claims Firing Was Retaliation for Whistleblowing at Previous Job

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

FDA Releases Finalized Q&A Guidance on Choosing Chemical Drug Starting Materials

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

TrueCare Biomedix Cited for Slew of Procedural Problems

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