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88 Total results for product and free and sample content found

Pink Sheet

Amarin's Vascepa: US FDA Panel To Scrutinize Breadth Of CV Risk Reduction

By Sue Sutter 13 Nov 2019

Analysis

REDUCE-IT enrolled a higher risk group than the broad population targeted by Amarin’s proposed indication statement, agency says; although reviewers conclude an interaction between the mineral oil placebo and statins cannot be excluded, any impact would have been small and unlikely to change overall treatment effect.

Topic Drug review FDA

Medtech Insight

Senators Question FDA's Proposed Progressive Approval Pathway For Devices

By Sue Darcey 13 Nov 2019

Article

US Democratic Sens. Elizabeth Warren of Massachusetts and Patty Murray of Washington State recently sent a letter to FDA officials Brett Giroir and Jeff Shuren that raises doubts about a planned bill calling for a progressive approval pathway for medical devices.

Topic FDA Policy and regulation

Medtech Insight

FDA Will Have To Scrape By On Continuing Resolution Funding Through December, Legislative Experts Predict

By Sue Darcey 13 Nov 2019

Article

While a government agency shutdown due to lack of agreement between Congress and the Trump administration over funding for the US Food and Drug Administration and other federal agencies seems less likely this year than last, the FDA will still have carry out its 2020 mission in the short term on 2019 continuing resolution funding – probably through December – legislative experts say.

Topic FDA Policy and regulation

HBW Insight

Homeopathic Market Doesn't 'Disappear' - FDA Forced To Act

By Malcolm Spicer 08 Nov 2019

Article

"This was an area that the agency thought was just going to disappear on its own," says Freddie Ann Hoffman, who chaired FDA homeopathic working group that helped develop CPG adopted in 1988 to allow sales of homeopathics to continue without pre-market approval.

Topic FDA Policy and regulation

Medtech Insight

Listen: Medtronic Exec Highlights Ethylene Oxide Standards At First Day Of FDA EtO Meeting

By Ferdous Al-Faruque 08 Nov 2019

Article

Medtronic’s director of quality sterilization and microbiology, Phil Cogdill, sat down with Medtech Insight to talk about setting new ethylene oxide (EtO) standards and what his takeaways were from the first day of a US FDA meeting to understand how to mitigate potential product shortages from closures of EtO sterilization facilities. Check out our podcast here.

Topic FDA

Pink Sheet

Zolgensma Data Integrity Fallout

06 Nov 2019

Novartis finds itself facing possible criminal or civil action for admitted data manipulation on its application for Zolgensma, a gene therapy used to treat children with spinal muscular atrophy (SMA) – manipulation disclosed only after FDA approval. Pink Sheet was the first to report on the drug’s loss of EU accelerated assessment, nearly 3 weeks before the pharma giant admitted to submitting falsified data to FDA. Follow the scandal and anticipate its implications on the industry with Pink Sheet’s coverage and timeline.

Topic Cell and gene therapy FDA

Pink Sheet

Webinar: FDA and its Commissioners

By Nielsen Hobbs 05 Nov 2019

Webinar

The US FDA has experienced an extended period with an acting commissioner. However, the agency continues to achieve its user fee dates, and hardly appears rudderless. Still, having a confirmed commissioner will give FDA more stability and power. But with application review looking to become more efficient and flexible, what could a new commissioner do to change the relationship between industry and FDA?

Topic FDA

Pink Sheet

Twirla Gets Strong Advisory Cmte. Endorsement Even After USA FDA Pans Application

By Michael Cipriano 05 Nov 2019

Article

The Bone, Reproductive and Urologic Drugs Advisory Committee voted 14-1, with one abstention, in favor of approving Agile's transdermal contraceptive patch Twirla in a sharp divergence from the US FDA's negative evaluation of the drug, though it remains an open question of how the agency will ultimately come down.

Topic Drug review FDA

HBW Insight

FDA Adds Homeopathic Enforcement Details, Subtracts Compliance Policy Guide

By Malcolm Spicer 01 Nov 2019

Homeopathy

Revised draft guidance identifies types of homeopathics posing "higher risks to public health." FDA withdraws 1988 compliance policy guide that allows homeopathic to be available even though they are not subject to pre-market approval or other review process agency imposes on all other drugs.  

Topic FDA Policy and regulation

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