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Drug Safety

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Latest From Drug Safety

Outpatient Rx Safety Meeting To Spotlight Health Literacy, Provider Communication

US FDA has made efforts to improve health communications to cater to deficiencies in literacy; other specific topics for discussion at the meeting remain unclear.

Drug Safety FDA

Invokana Adds Warnings On Amputation Risk, But Will It Give Jardiance An Edge?

New data from J&J's cardiovascular outcomes trials shows leg and foot amputations occurred about twice as often in diabetes patients treated with canagliflozin versus placebo.

BioPharmaceutical Regulation

Smartphone Apps Appropriate For OTC Product Instructions – Consultant

“The present has passed us by” in using appropriate technology to provide consumers more information than on US Drug Facts labels, Pinney Associates’ Saul Shiffman says at CPHA conference.

Consumer Drug Safety

Safety Events For Accelerated Approval Drugs Highlighted As Expansion Looms

US drugs with accelerated approval are more likely to experience a postmarket safety event, JAMA study finds; data sharing could be a solution to filling information gaps.

Drug Safety Post Market Regulation & Studies

Drug Importation Blocked But Not Forgotten As User Fee Bill Clears Senate Cmte

Amendment from Sen. Sanders was tabled in part to avoid adding a controversial provision that could slow the bill's passage, but may be debated during upcoming drug costs hearing.

FDA Legislation

Codeine Concerns Cough Up FDA's OTC Monograph Problems

Pew Charitable Trusts joins CHPA, medical groups in urging Congress to authorize moving the US monograph system to an administrative process and to authorize a monograph user fee program.

Consumer Drug Safety

Black Box 'Best Case' Hopes On Vaginal Estradiol Dashed For TherapeuticsMD

Echoing complaints of other recent complete response recipients, TherapeuticsMD charges that US FDA's request for 12-month safety data for the dyspareunia therapy TX004HR is not consistent with earlier communications with agency.

Complete Response Letters Drug Safety

User Fee Add-Ons: Senate Bill Tweaks Orphans, Opioids, Patient Data

Manager's amendment tells US FDA to issue more guidance for complex generics and tells GAO to report on progress towards global harmonization of data standards.

Legislation FDA

FDA’s Remarkable ALS Drug Approval: Call It The 'Hendeles Standard'

US FDA’s approval of Mitsubishi's Radicava (edaravone) is yet another demonstration of the agency’s flexibility for drugs to treat rare diseases – and pre-emptive action to fend off “Right to Try” laws. It is also a belated endorsement of one of the stranger votes by an FDA advisory committee member almost a decade ago.

Drug Approval Standards Advisory Committees
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