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Regional Coverage

Asia Pacific

Set Alert for Asia Pacific

Latest From Asia Pacific

US FDA Warns Torrent Over Losartan Process Validation, OOS Invalidation Failures

Warning letter stemming from global nitrosamine investigation raises new concerns about Indian manufacturer.

Quality Enforcement

Defying FDA: Shanghai Lab Gets Warning Letter But Won’t Relent

A Shanghai testing laboratory has been handed an FDA warning letter for refusing a GMP inspection but has shot back at the US agency, saying it rightfully did so.

China Manufacturing

Global Pharma Guidance Tracker – September 2019

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

International Europe

'Project Orbis' Oncology Pilot Eventually Will Target 'Major Impact' Applications

But US FDA is starting small, OCE Director Pazdur says. Program will hand-select approve high-priority oncology treatments that have to potential to change the standard of care.

Cancer Drug Review

A Warning Letter Trend Surprise: Good In India, Bad In South Korea

A comparison of US FDA inspection and warning letter rates find India performs much better than China and South Korea.

Quality Enforcement

US FDA Warns Lupin Again About Poor Batch Failure Investigations

Agency demands review of invalidated out-of-specification findings as root causes of failures continue to elude Indian drugmaker at multiple facilities.

Manufacturing Quality
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Set Alert for Europe

Latest From Europe

Loud And Clear: EMA Gets Message On Advancing Reg Science

The European Medicines Agency has identified key areas where stakeholders want to see it deliver a real change over the next five years.

Europe Regulation

More No-Deal Guidance As UK Parliament Slows Brexit Timetable

With two key votes in parliament leaving the Brexit outlook still as clear as mud, the government is pressing on with its no-deal guidance. 

United Kingdom Brexit

Vertex Strikes Spanish Payment-For-Results CF Deal

Vertex has struck a reimbursement deal in Spain for Orkambi and hopes that it will also make progress in England where a new proposal has been made by the company.

Europe Spain

EMA Tackles Tricky Business Of Defining Therapeutic Indications

The European Medicines Agency has identified key elements that regulatory reviewers should consider when evaluating the therapeutic indications proposed by companies.

Drug Review Europe

French To Press On With Rapid Trial Approval System

A French pilot intended to speed up the authorization of clinical trials is to be continued after a pilot phase showed it was working well.

France Clinical Trials

Scotland Explains How To Tackle No-Deal Drug Shortages

Scotland’s government has consistently opposed the UK’s departure from the EU, and has been putting its own measures in place to deal with any medicines shortages that might arise in the event of a no-deal Brexit.

United Kingdom Brexit
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United States

Set Alert for United States

Latest From United States

Sprout’s Addyi Loses Blanket Alcohol Contraindication And REMS Distribution Restrictions

US FDA’s approval of labeling supplements for the hypoactive sexual desire disorder drug followed Sprout’s appeal of a safety-related change order; boxed warning now states patients should wait at least two hours after drinking alcohol before taking flibanserin.

Drug Safety Post Market Regulation & Studies

Vyleesi Reviewers

US FDA staff who participated in the review and approval of AMAG’s bremelanotide for hypoactive sexual desire disorder.

Drug Review Profile Approvals

Vyleesi’s Approval Delayed By Blood Pressure Study Conducted During NDA Review

Although the US FDA first recommended a dedicated ambulatory blood pressure monitoring study in March 2017, AMAG did not move forward with such a trial until late 2018 and only after the agency said the results were needed prior to approving bremelanotide, the Pink Sheet's latest Drug Review Profile finds.

Drug Review Profile Approvals

Vyleesi Cinical Development Timeline

Chronicle of the development and review of AMAG Pharmaceuticals’ bremelanotide for premenopausal women with acquired, generalized hypoactive sexual desire disorder.

Drug Review Profile Approvals

AMAG’s Vyleesi Review Offers Lessons On Impact Of Patient Input

US FDA accepted change in Phase III endpoint hierarchy for the hypoactive sexual desire disorder drug based on input from a patient-focused drug development meeting and scientific workshop; bremelanotide review documents advise on use of multiple anchor scales to help interpret meaningfulness of changes in clinical outcome assessment scores.

Drug Review Profile Approvals

Accelerated Approval: Midodrine Experience Shows Regulatory Challenge US FDA Faces With Makena

The orthostatic hypotension treatment midodrine has been on the market for more than 20 years despite the failure of postmarketing studies to confirm clinical benefit; an advisory committee soon will weigh the future of AMAG’s preterm birth drug Makena, which failed its confirmatory trial required as a condition of accelerated approval.

Post Market Regulation & Studies Review Pathway
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