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Latest From Drug Safety

Sabine Straus To Lead EMA's Pharmacovigilance Committee

Dutch regulator Sabine Straus will take over as chair of the European Medicines Agency's Pharmacovigilance Risk Assessment Committee when the UK’s June Raine leaves the post this year.

Drug Safety Risk Management

CDER Safety Overhaul Planned As Review Process Modernization Continues

US FDA's Woodcock tells the Pink Sheet that goals include eliminating duplication through creation of one safety review process.

Drug Safety FDA

EU Regulators Recall Valsartan Products Produced In China

Stada and Accord are among the companies affected by an EU wide recall of valsartan manufactured by a Chinese supplier.

Europe China

Opioid Litigation: Drug Mfrs. Lose Bid To Limit Data Disclosure; First Trials Set For March

US court orders firms to release information on all opioid products ever classified as Schedule II from one year prior to launch date; government, manufacturers oppose public disclosure of DEA distribution data.

Advertising, Marketing & Sales Legal Issues

Remoxy Review Shows How Opana ER Experience Changed US FDA Thinking On New Opioid Formulations

Pain Therapeutics CEO Barbier says comparing Remoxy to Endo's withdrawn Opana ER 'borders on slanderous' and asserts that after three complete response letters, FDA is once again moving goalposts for approval.

Advisory Committees Drug Safety

Addition Of Celebrex PRECISION Cardiovascular Trial to Label Emphasizes Use Of Lowest Dose

Heeding concerns of an advisory panel, US agency underscores that it is the lowest approved dose of the COX-2 inhibitor that has comparable CV risk to moderate doses of ibuprofen and naproxen.
Drug Safety Approvals

US FDA Seeking More ‘Open Access’ To Real World Data From Payers

Agency is paying “enormous sums” to access postmarket information from payers, Commissioner Gottlieb says, suggesting public-private partnerships to enhance access.

Drug Safety Private Payers

Remoxy Review Leaves US FDA Wondering: Where Is The Real-World Data On ADFs?

FDA’s Sharon Hertz opened up an advisory committee review of PTI’s proposed abuse-deterrent formulation of Remoxy by remarking on the absence of data about the real-world impact of approved ADFs. That doesn’t have much to do with Remoxy – which appears headed to yet another rejection – but it is an important message for other sponsors of opioid therapies to heed.

Advisory Committees Drug Safety

Dealing With Brexit: EMA Offers Firms Advice On More Thorny Questions

The European Medicines Agency has updated its guidance on Brexit to offer companies more advice on the regulatory changes they will need to make in areas like transfers of MAs, rapporteurships and orphan designations, multi-country packs, and Article 58 opinions.

Brexit United Kingdom
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