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
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
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
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
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
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.
Biomedtracker: 開発中医薬品をFDA承認確率で評価
16 Oct 2019
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
16 Oct 2019
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.
Biomedtracker: 開発中医薬品をFDA承認確率で評価, Datamonitor...
27 Sep 2019
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.
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