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Drug Safety

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Latest From Drug Safety

A Big Week For FDA’s Top Eye Drug Reviewer

Ophthalmology supervisory medical officer Wiley Chambers played a key role at three different advisory committee meetings in early October. Only one was a review in his division.

Advisory Committees Drug Review

Australian Black Triangle Scheme To Start in 2018

From next year drug manufacturers operating in Australia will have to start placing a black triangle symbol on the product information and consumer medicines information documents for certain newly approved prescription products and new indications.

Australia Drug Safety

Liraglutide Generics May Need More Robust Analytical Methods After Novo Petition

ANDA pathway is not sufficient to review liraglutide generics because of molecule's complexity, Novo contends; Teva appears to be first filer for Victoza.

Generic Drugs Drug Safety

Australia Moves Forward With Biovigilance Guidelines

Australia’s regulator has responded to consultation submissions and is moving forward with plans to issue guidance on biovigilance.

Australia Biologics

Opioid Hearing: Senators Want Speed, But Agency Heads Stress Time, Effort

Reeducating prescribers on treating pain will take a long time, FDA Commissioner Scott Gottlieb tells Senate HELP Committee Members.

Drug Safety Legislation

FDA's Opioid Programs: After Training, What's The Next Step?

Treatment guidelines may also appear in opioid labeling, and insurers seem to be taking the agency's advice, but will it be enough to satisfy Congress?

FDA Legislation

Gottlieb Issues Statement On Adverse Event Limitations – An Attempt To Quell Fears?

Commissioner Scott Gottlieb's statement noting the limitations of FAERS comes just four days after he was quoted in an FDA announcement about the launch of a more searchable portal for the adverse event database.

Drug Safety Post Market Regulation & Studies

CDER Safety Outcomes Trials Group Vetted Kevzara CV Study Need

Lipid increases in sarilumab's clinical program spurred consideration of a cardiovascular outcomes trial postmarketing requirement akin to that conducted for Genentech's Actemra. However, Medical Policy Council's new subcommittee recommended against requiring a study, citing feasibility concerns.

Drug Review Profile Drug Review

AmerisourceBergen Oncology Drug Repackaging Program Draws $260m Fine

Now-defunct AmerisourceBergen subsidiary inappropriately repackaged oncology support drugs like Neupogen and Procrit in pre-filled syringes, violating the law and prompting safety concerns, Department of Justice announced.

Compliance Legal Issues
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