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Latest From Drug Safety
Homeolab USA’s and Cellex-C’s imports were stopped earlier in 2017 following GMP inspections at their facilities, and FDA warns that approvals for marketing of additional products in the US could be withheld until each firm is GMP-complaint. Homeolab trips up by trying to prevent FDA photography inside plant.
After receiving delayed visas, additional FDA is inspectors and other staff can relocate to China office; Gottlieb also announces increase in international mail facility staff.
The National Health Service in England has drawn up a proposed list of “ineffective and dangerous” medicines that should not be routinely used in primary care, in a move to conserve resources and improve patient outcomes. They include products containing substances like fentanyl, tadalafil and trimipramine, as well as homeopathics and traditional herbal medicines.
Mexico has published guidelines on pharmacovigilance that bring Mexican practices in line with international standards.
The Italian regulatory body AIFA has announced a new system allowing the public and health professionals access to information held on the national database of adverse drug reactions. The database can be searched by brand name or active ingredient.
The biotech now only needs to investigate liver toxicity in 6,000 patients – down from 9,000 – to refile its NDA, but Cempra made clear that it won't initiate the study without an external funding source.
Drug makers preparing for the launch of the enhanced EudraVigilance database in the EU will soon be told about any plans, arrangements and requirements that are specific to the national competent authorities.
Safety concerns have prompted drug regulators in Europe to call for the replacement of methylprednisolone injections that contain lactose from cow’s milk with lactose-free formulations.
Dynavax's final pivotal trial for hepatitis B candidate was missing data from 150 patients, making its causality of myocardial infarctions unclear; the question now is whether the postmarketing trial can answer the question.
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