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34 Total results for product and free and sample content found

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

A Visual Guide To US FDA's Evolutionary Decade In Review

16 Jan 2020

An interactive timeline shows the news of the past decade and the evolution of US FDA policies. Click on each year for a full list of events and see the accompanying article.

Topic fda policy-and-regulation

Scrip: 世界の医療用医薬品&製薬産業に関するニュース

O’Day Lays Out Plan For Gilead’s Continued HIV Dominance

15 Jan 2020

Biktarvy’s powerful sales growth and the potential of a first-in-class capsid inhibitor in both prevention and heavily treatment-experienced patients are key to Gilead’s plan for staying on top in HIV.

Scrip: 世界の医療用医薬品&製薬産業に関するニュース

Korea 2020 Outlook: Hopes Of Turnaround Amid Potential Deals, Biosimilar Launches, Biologics Law

By Jung Won Shin 15 Jan 2020

After a year full of disappointing and unexpected events, the South Korean pharma sector is hoping for a turnaround in 2020, with expected biosimilar launches in global markets, progress in drug pipelines, large IPOs and implementation of a new law on cutting-edge biologics.

Topic clinical-trials deal-trends

Generics Bulletin: ジェネリック&バイオシミラーニュース

California Plans To Create Own Generics Label

15 Jan 2020

California’s 2020-2021 fiscal budget includes plans to work with manufacturers to establish the state’s own generics label. But industry is sceptical that the initiative will deliver the savings that the US state hopes for.

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Sharfstein: US FDA Incentives Not Broke, But Fix Them

15 Jan 2020

The former US FDA principal deputy commissioner argues that accelerated approval, fast track and breakthrough designation standards may need updating, along with orphan and pediatric exclusivity requirements, to enhance the programs' efficacy.

Medtech Insight: 世界の医療機器・医療技術の最新情報

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 1)

15 Jan 2020

Compliance_Corner_Part_1

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this first installment of a 10-part series, a procedure for hosting inspections is addressed.

Medtech Insight: 世界の医療機器・医療技術の最新情報

Exec Chat: CES 2020: For FDA's Amy Abernethy It's About Data, But Also Community Engagement

15 Jan 2020

Amy Abernethy, FDA's principal deputy commissioner, sat down with Medtech Insight during CES 2020 to discuss the agency's progress on the Technology Modernization Action Plan, the pre-certification program for digital health products, and the FDA's plans for 2020.

Topic Digital Health FDA

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

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

By Sue Sutter 08 Jan 2020

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.

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

US FDA Approval Of Lynparza For Pancreatic Cancer Opens Door For PFS Endpoint In Disease

08 Jan 2020

US_FDA_Approval_Of_Lynparza_1

AstraZeneca's PARP inhibitor Lynparza becomes first US FDA-approved drug for pancreatic cancer based on progression-free survival endpoint, providing regulatory precedent for other sponsors to use that development approach; all other pancreatic cancer drugs had been approved based on an overall survival benefit.

Topic cancer clinical-trials

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