skip to main content
Close Icon We use cookies to improve your website experience.  To learn about our use of cookies and how you can manage your cookie settings, please see our Cookie Policy.  By continuing to use the website, you consent to our use of cookies.
Global Search Configuration
  • Close Icon

Refine Results

Clear All

Specialism

Show More

Resources

Show More

Show More

Products

Show More

Show More

95 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

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.

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

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

13 Nov 2019

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

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

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

05 Nov 2019

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

Scrip: 世界の医療用医薬品&製薬産業に関するニュース

Interview: Why Europe's Biotech Prime Time Is Now

By sten-stovall 23 Oct 2019

VC Firm Sofinnova’s Chair Papiernik Speaks After New Fund Launch The chairman of Sofinnova Partners told Scrip his newly launched biotech start-up fund aims to profit from Europe’s top science, relatively realistic asset prices, and geopolitical position between the US and China.

Topic business-strategies drug-review

Biomedtracker: 開発中医薬品をFDA承認確率で評価

Q3 2019 Catalyst Roundup

16 Oct 2019

Q3 2019 Catalyst Roundup

What were the outcomes of critical catalysts featured in Biomedtracker’s Q3 2019 Outlook Report? Find out in the Catalyst Roundup: A Review of Select Catalysts from Last Quarter’s Outlook Report. This data-rich graphic is available now – for free.

Topic Drug approval Drug review FDA

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Pink Sheet Performance Trackers: Navigate a complex world with the regulatory performance trackers from Pink Sheet

16 Oct 2019

 Pink Sheet Performance Trackers: Navigate a complex world with the regulatory performance trackers from Pink Sheet

Keep track of compliance, legislation, policy regulations, and industry developments with the expertise of our worldwide network of expert analysts and journalists on the ground in key global regions.

Topic drug-development-landscape drug-review fda

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

Key potential drug launches 2020

27 Sep 2019

Key potential drug launches 2020

Take a longer-term look at key late-stage drugs projected to hit the market in 2020, including new drug classes, major changes to standards of care, and/or large market opportunities across the wide range of indications covered by Biomedtracker and Datamonitor Healthcare.

Topic drug-approval drug-review drug-development-landscape

お問い合わせ&レポートストア

専任スタッフによるデモンストレーションを兼ねたサービスの詳しいご説明、または無料トライアルを常時受け付けています。ご希望の場合は下記のフォームよりお気軽にお申し込みください。

*一部のサービスでは無料トライアルをご利用になれません。

ご質問等ございましたらお気軽にご連絡下さい。

日本(平日:9時~18時)
電話:+81 (0)3 6273 4260
Email:inquiry.jp@informa.com

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。

お探しの情報が見つからない場合はお問い合わせ先までお気軽にご連絡ください。