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Biomedtracker: 開発中医薬品をFDA承認確率で評価, Datamonitor...

2020 Early Outlook Webinar

Anticipate the biggest, most impactful expected catalysts of early 2020 with the guidance and insights from Pharma Intelligence. Building off Biomedtracker’s Early 2020 Outlook report, our live webinar will include market context for these upcoming milestones and additional insights from Datamonitor Healthcare’s Therapeutic Area Directors.

Topic fda

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

For Coronavirus US FDA Is At The Podium But Not On The Task Force

The FDA is curiously not one of the HHS entities coordinating the US response to the outbreak, but must monitor for manufacturing disruptions and shortages, as well as approve new treatments and diagnostics.

Topic fda vaccines infectious-diseases Coronavirus

Medtech Insight: 世界の医療機器・医療技術の最新情報

QUOTED. 24 January 2020. Megan McSeveney.

The FDA has readied plans for hastened emergency-use approvals of coronavirus test kits after an infected US citizen returned to Washington State from Wuhan province in China. See what the FDA’s Megan McSeveney said about it here.

Topic Drug approval Coronovirus FDA

HBW Insight : コンシューマーヘルスケア産業のニュース

OTC Drug Oversight By US FDA Split Among Two Divisions In Reorganization

OTC_Drug_Oversight_By_US

CDER Office of New Drugs changes its organization including establishing Office of Nonprescription Drugs and splitting the office into Division of Nonprescription Drug Products I and DNDP II. A Division of Regulatory Operations for Nonprescription Drugs will be comprised of regulatory staff from the ONPD divisions and will report to OND’s regulatory office. Non-clinical ONPD staff will report to the office director.

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

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

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)

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

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

Medtech Insight: 世界の医療機器・医療技術の最新情報

FDA Will Keep Listening To Patient-Engagement Experts

FDA_Will_Keep_Listening

The US agency says in a 6 January Federal Register notice that it’s keeping its Patient Engagement Advisory Committee in place through October 2021 so it can gather more patient feedback that will come in handy when regulatory decisions need to be made. The committee, formed after the agency made a cultural shift to consider patient input on the types of products it allows on the market, was supposed to expire October 2019.

HBW Insight : コンシューマーヘルスケア産業のニュース

'Supplement' on CBD Product Label A Bullseye For US Litigants, Says Attorney

Two CBD marketers warned by FDA in a recent crackdown are targeted in class action complaints alleging they made unsubstantiated health claims and mislabeled ‘illegal drug’ products as supplements. Complaints are a wake-up call to CBD wellness industry to ensure claims are substantiated, as the class action bar is on the prowl following the agency’s 15 warning letter blast in November.

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オンラインショップのレポートストアでは、医療用医薬品の市場調査・分析レポートを常時1000本以上販売しています。レポート1本単位で購入でき、オンラインでご提供いたします。

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