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Latest From Joanne Eglovitch
US FDA official warns the pharmaceutical industry that investigators will continue to look for data integrity problems during inspections, and discusses “red flags” observed in inspections.
FDA’s Pharmacy Compounding Advisory Committee votes to place coated modified release drugs on the “difficult-to-compound” list, thus barring these drugs from being compounded in the foreseeable future. The committee agreed with FDA’s recommendations that the complex formulation and the difficulty in manufacturing them precludes them from being compounded at the current time.
US pharmaceutical industry is warned that products “will not flow through the supply chain if the digital data is not right” under DSCSA, says official. Law’s second phase, which takes effect in November, mandates first-ever digital serialization requirements to ward off drug counterfeiting.
Regulators and industry officials agree that despite efforts to spur development of continuous manufacturing, uptake has been slow globally. FDA still is on learning curve and acknowledges a knowledge gap around some of the higher order principles associated with continuous manufacturing.
Regulators and manufacturers worldwide intensify cracking down on the scourge of counterfeit drugs, with APEC launching a toolkit, industry recruiting participants for a shared audit program and WHO warning that the problem is not going away anytime soon. While anti-malarials and -infectives and vaccines continue as prime targets, a new trend is emerging in “well-regulated’ markets of high-priced hepatitis drugs falsified.
Industry and regulatory working group participants are grappling with established conditions and post-approval change management protocols in developing early ICH Q12 draft guidance. Latest proposal calls for three post-approval change categories.