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Drug Safety

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Latest From Drug Safety

GMP Problems Stop Canadian Firms’ Topical OTC, Homeopathic Imports

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.

Consumer Manufacturing

US FDA's China Staff Increase Takes Hold As Gottlieb Boosts Border Security

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.

Compliance Drug Safety

NHS England Tackles Use Of ‘Ineffective And Dangerous’ Medicines

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.

Cost Effectiveness Drug Safety

Mexico Introduces New Pharmacovigilance Guidelines

Mexico has published guidelines on pharmacovigilance that bring Mexican practices in line with international standards.

Mexico Drug Safety

Italy Opens Up ADR Database To The Public

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.

Drug Safety Italy

Cempra Gets Easier Path To CRL Response, But Who Will Fund The Study?

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.

Complete Response Letters Drug Safety

EMA To Clarify Member State-Specific Requirements For New EudraVigilance System

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.

Europe Post Market Regulation & Studies

EU Regulators Demand Reformulation Of Methylprednisolone Injections

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.

Europe Drug Safety

Heplisav Postmarketing Worries Push PDUFA Date Back; FDA Seeks More Details

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.

Advisory Committees Vaccines
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