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79 Total results for product and free and sample content found

Biomedtracker: 開発中医薬品をFDA承認確率で評価

Q3 2019 Catalyst Roundup

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

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

Scrip: 世界の医療用医薬品&製薬産業に関するニュース

Opioids Crisis Commercial Implications for an Embattled Industry

14 Oct 2019

Opioids Crisis Commercial Implications for an Embattled Industry

Find out how the consequences of the opioids crisis is affecting the pharma industry, from shaping the way deals are made, to transforming the development of new categories of drugs. Scrip brings you the implications behind the headlines in an essential free article pack.

Topic drug-development-landscape fda

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

The Opioids Crisis Regulatory Response to an Epidemic

14 Oct 2019

The Opioids Crisis Regulatory Response to an Epidemic

With the opioid crisis in full swing in the US, government and regulatory agencies are announcing changes to guidance and legislation related to both new and existing drugs. Keep abreast of these critical changes with essential coverage from Pink Sheet.  

Topic Drug approval FDA

Scrip: 世界の医療用医薬品&製薬産業に関するニュース

An AdComm After All: Amarin's Vascepa Labeling Update Now Delayed By FDA

15 Aug 2019

An AdComm After All: Amarin's Vascepa Labeling Update Now Delayed By FDA

The US FDA informed the company it will convene an advisory committee meeting to review the REDUCE-IT sNDA for the proprietary fish oil pill, delaying the approval by at least three months and surprising investors.

Topic fda drug-approval

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Novartis' Zolgensma Had Manipulated Data In Application, US FDA Says

14 Aug 2019

Novartis' Zolgensma Had Manipulated Data In Application, US FDA Says

Gene therapy should remain on the market, FDA says, but Novartis could face civil or criminal penalties. Firm knew of problems before approval.

Topic fda company-analysis

Medtech Insight: 世界の医療機器・医療技術の最新情報

Compliance Corner: FDA Investigator Sees These 4 Common Sterilization Problems When Inspecting Facilities

By Shawn M. Schmitt 14 Aug 2019

Compliance Corner: FDA Investigator Sees These 4 Common Sterilization Problems When Inspecting Facilities

Phil Pontikos, who is also the US agency's national device expert, explains how device-makers can avoid running afoul of the FDA's rules and expectations for sterilization activities.

Topic fda

Medtech Insight: 世界の医療機器・医療技術の最新情報

US and EU Guidance Report

06 Aug 2019

US FDA says as artificial intelligence and machine learning offer new opportunities to improve patient care, the agency hopes to encourage innovation by developing a draft guidance on the issue for sponsors. It also released a discussion paper outlining key issues it wants feedback on from industry and other key stakeholders.

Topic FDA Digital Health Medtech

Medtech Insight: 世界の医療機器・医療技術の最新情報

One Small Step For US FDA, But Maybe A Giant Leap For SaMDs

By ferdous-al-faruque 26 Jul 2019

One Small Step For US FDA, But Maybe A Giant Leap For SaMDs

In a midyear update from the FDA, regulators say a retrospective review of companies in its pre-cert pilot program has concluded that evaluating a company for excellence markers could be sufficient to let Software as a Medical Device (SaMD) onto the market. However, at least one critic says the update doesn’t answer some of the most critical questions about whether the program meets the agency's own requirements and if it creates unfair advantages for certain companies.

Topic FDA Policy and regulation

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