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Real-Time Release Of CRLs Is US FDA’s Goal, Agency Leaders Affirm

The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.

No Surprise Here: Foreign Drug Facilities Should Expect Surprise Inspections, US FDA Says

The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.

Base Benefit-Risk Decisions On Data, Not Opinion And Passion, CDER’s Tidmarsh Says

New US FDA drugs center director George Tidmarsh’s data-centric comments at a Reagan-Udall Foundation meeting on unapproved fluoride products could suggest patients’ and caregivers’ experiences will carry less weight in benefit-risk decisions under his leadership.

Gilead’s Yeytuo, Lilly’s Kisunla Headline CHMP Positive Opinions

Yeytuo will have remaining challenges to PrEP to overcome, while Kisunla’s label reflects dosing titration data from a Phase IIIb study to mitigate ARIA-E.

Blenrep Review Highlights US FDA Oncology Trial Site Selection, Comparator Issues

The FDA will take a hard line on trial design and site selection to ensure applicability to the US, Oncology Center of Excellence Director Richard Pazdur said during a meeting on GSK's Blenrep.

AI Is Inevitable, But Useful Only If Solves The Right Problems

Scrip spoke with executives at artificial intelligence biotech firms and a big pharma company during the recent BIO conference about using AI in ways that add real value to drug development.

Drug Sponsors Can Help Shape Agenda For FDA/EMA Pediatric ‘Cluster’ Calls

Companies can propose specific issues for discussion during the regulators’ monthly teleconferences, which focus on finding areas of agreement and reasons for nonalignment on specific pediatric development plans or general issues.

Pharma Companies Suspecting Clinical Trial Fraud Should Move Quickly, Quietly

Sponsors should investigate signals of possible fraud in a manner that does not raise alarms or else evidence might disappear, UK and US regulators said.

Scrip is an invaluable source of information and insight about key developments in the biopharmaceutical industry. It has produced some of the most detailed reporting about emerging therapeutics in our field (the liver disease nonalcoholic steatohepatitis), with crisp perspective on scientific, business and regulatory dynamics.

Chris Frates, VP of Corporate Communications and Patient Advocacy
Madrigal Pharmaceuticals

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2003
Generics Bulletin

News and Expert Analysis on Generics and Biosimilars

1981
In Vivo

Strategic Analysis for Medtech and Pharma Leaders

1980
HBW Insight

News and Expert Analysis on the Healthcare Industry

1975
Medtech Insight

News and Expert Analysis for Medtech Decision Makers

1972
Scrip

Pharma News and Expert Analysis for Commercial Decision Makers

1939
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News and Expert Analysis on Pharma Policy and Regulation

1906
US FDA

Beginnings of
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Karen Coleman

Karen Coleman

Executive Director,
News and Insights

Ian Haydock

Ian Haydock

Editor-in-Chief,
APAC

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Nielsen Hobbs

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Pink Sheet

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Eleanor Malone

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Andrea Charles

Vice President
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