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Policy & Regulation

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Opana Withdrawal Request Builds On US FDA Actions On Palladone, OxyContin

Earlier withdrawals of Purdue’s Palladone and original OxyContin create precedent for request that Endo’s Opana ER come off market due to risk of abuse; former chief counsel sees agency's move as ‘tip of the iceberg’ on opioid safety actions.

Drug Safety Post Market Regulation & Studies Neurology

Valproate In The Spotlight As EMA Releases Date For First Ever Public Hearing

The European Medicines Agency has released the date for its public hearing on valproate in which EU citizens will for the first time be given a voice in evaluating the safety of medicines on the market.

Pharmacovigilance Post-Marketing Europe
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Regulation

Set Alert for Regulation

Latest From Regulation

EFPIA Calls For Interim Accords To Ease Brexit Impact

As the first day of Brexit talks highlighted how lengthy and complex the negotiations over the UK’s departure are going to be, Europe’s drug makers are pushing for transitional measures to be in place to keep disruption to regulation and health care to a minimum.

Europe Brexit

FDA's NDA And BLA Approvals: Cotempla XR-ODT, Baxdela, Mydayis, Rituxan Hycela, Haegarda

Original new drugs and biologics recently approved by US FDA.

Approvals Regulation

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

EU Postpones Decision On EMA’s New Home To November

The decision on where the European Medicines Agency should be located after the UK leaves the EU has been postponed to November. The European Council has published details of the bidding process countries must follow if they want to host the EMA.

Brexit Europe

Canada Aims To Implement eCTD v4 By 2022

Canada joins other international regulators in announcing plans to implement the next major revision of the electronic common technical document format (eCTD v4). A roadmap has been issued to help pharmaceutical companies prepare and plan for this change.

Regulation Drug Approval Standards

Majority Of British Public And GPs Don’t Trust Drug Industry, UK Review Confirms

The Association of the British Pharmaceutical Industry is to discuss the recommendations from a report requested by the Chief Medical Officer for England that has found that most UK adults and general practitioners do not trust pharma.

Drug Review United Kingdom
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Policy

Set Alert for Policy

Latest From Policy

FDA Getting Reg Slashing Directive In Trump Executive Order

Draft order wants "comprehensive review" to find regulations that that "unnecessarily increases expenses" for patients, researchers, and manufacturers.

Pricing Debate Generic Drugs

Trump Exec Order On Drug Costs: Seeking To Balance Access, Innovation

Draft version of order signals a focus on insurance benefit design, accelerating drug approvals and de-regulation.

Pricing Debate Market Access

White House Mulls Proposal To Pause FDA's Quality Metrics Initiative

Trump administration briefing materials show that the pharmaceutical industry's complaints about FDA's quality metrics initiative are getting high-level attention.

Quality Manufacturing

Pricing Deregulation: 340B Pharmacy Policy, Medicaid Payment Rules May Be Withdrawn

Trump administration's drug pricing action plan considers withdrawing guidance and whole or parts of rules that biopharma has opposed.

Pricing Debate Medicaid

Could Trump’s NAFTA Renegotiation Hit Canadian Drug Price Controls?

Thanks to forthcoming NAFTA renegotiations, the US could put Canada under pressure to rethink its plans to curb excessive pricing.

Canada United States

Support For Continued EU Co-operation On Health Technology Assessment Is ‘Overwhelming’

Support is strong for continuing EU co-ordination on health technology assessment, according to a report on the responses to a consultation on the topic. An impact assessment on what will follow the EUnetHTA Joint Action 3 will come in late 2017.

BioPharmaceutical Europe
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