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Drug Safety

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Latest From Drug Safety

‘Real World’ Opioid Abuse Data On OxyContin Again Under Review At US FDA

Resubmission comes more than four years after Purdue pulled an sNDA seeking to demonstrate ‘real-world’ abuse prevention.

Real-World Evidence Neurology

Postmarketing Trial For Horizon Thyroid Eye Drug Tepezza To Be Larger Than Expected

Horizon CEO says safety trial will be conducted in a larger patient population following discussions during the US FDA advisory committee meeting.

Post Market Regulation & Studies Approvals

US FDA Drug Risk Management Board To Be Lead By CDER Deputy Cavazzoni

CDER Director Woodcock announced that the drug center will soon launch the Drug Risk Management Board, which will coordinate product safety activities among the different offices; Patrizia Cavazzoni, who serves as CDER's deputy director of operations, will chair the board.

Drug Safety FDA

EMA Suspends Leo’s Actinic Keratosis Drug Picato

The latest drug safety actions by the European Medicines Agency affect products for dermatological use and vaginal atrophy.

Europe Drug Safety

Opioid-Sparing Hopes, Efficacy Worries Drive Inconclusive Advisory Cmte. On Durect's Posimir

US FDA's advisors produce tie vote on bupivacaine extended-release solution for post-surgical analgesia; proponents valued its potential to to cut opioid use, while opponents questioned its efficacy.

Advisory Committees Drug Review

US FDA’s End-Of Year Approval ‘Rush’ And Other Criticisms: Fact Or Fiction?

FDA has been criticized in recent months for approving drugs too quickly, based on insufficient evidence. The agency’s oncology chief Richard Pazdur fights back.

Cancer Drug Approval Standards

Durect's Posimir: NDA Resubmission Raises Similar Safety Issues

How to score adverse events for Durect's surgical pain treatment could determine whether US FDA advisory committee recommends bupivacaine extended-release solution; agency questions whether Posimir's formulation may cause neurological adverse events.

Advisory Committees Drug Safety

US FDA’s Precision Medicine Efforts Turn Towards Adverse Events

Next PrecisionFDA challenge aims to detect ‘adverse event anomalies’ including manufacturer-specific patterns and drug-drug interactions.

Drug Safety Personalized Medicine

US FDA Postmarketing Drug Safety Modernization Plan Will Cut Across Review Disciplines

Detection of nitrosamine impurities in some marketed drugs highlights need for standardized, consistent approach to systematically monitor risks of drugs throughout their lifecycles, CDER’s Janet Woodcock says. Safety monitoring overhaul is lagging behind new drug review modernization effort, but implementation is expected to begin in 2020.

Drug Safety Drug Review
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