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25 Total results for product and free and sample content found

Medtech Insight: 世界の医療機器・医療技術の最新情報

FDA Clears CDC Diagnostic For COVID-19 And Influenza

mti-FDA-Clears-CDC

The US FDA has authorized marketing of a combination diagnostic that can detect either COVID-19 or influenza. The agency hopes to encourage development of additional similar tests before the fall flu season.

Topic Coronavirus Diagnostics In Vitro Diagnostics Regulation

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

New Leader & Reorgs at Key Regulatory Agencies

Pink Sheet invites you to go inside the recent personnel changes at key regulatory agencies around the globe – including US FDA, EMA, and England’s NICE – and how these new appointments will likely influence future regulation of the biopharma industry.

Topic Regulation

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Pink Sheet European Regional Coverage

Pink Sheet European Regional Coverage

Gain insights into new European regulatory events and developments with expert coverage from Pink Sheet. You’ll discover vital news and insight regarding Brexit, approvals for novel therapies, drug safety related updates, and more from our worldwide and on-the-ground team of expert journalists and analysts.

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

European Performance Tracker

European Performance Tracker

Explore European coverage with informative articles covering recent regulatory and policy developments in the region.  We now invite you to go even deeper, with regulatory market intelligence from Pink Sheet’s European Performance Tracker.

Generics Bulletin: ジェネリック&バイオシミラーニュース

Australian Bodies Set Out Joint Position On Coronavirus

Australia’s off-patent industry association, the GBMA, and local brand organization Medicines Australia have set out their plans for collaborating on supplying essential medicines amid the coronavirus pandemic.

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Stress Test: Coronavirus Challenges China Emergency Approval Mechanism

72 Products Approved Under Expanded Emergency Pathway A regulatory pathway set up in China post-SARS is under stress test in the latest coronavirus outbreak, while emergency measures adopted by the country's regulator mean it’s much less burdensome to obtain approvals than before.

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

UK Firms Asked To Check Coronavirus Supply Chain Impact

Authorities Also Investing In Vaccines And Tests Amid concerns that the coronavirus outbreak could have an impact on the supply of APIs and other materials sourced from Chinese manufacturers, pharmaceutical companies are to assess their supply chain situation to help ensure patients do not experience medicine shortages.

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

FDA Broke Catalyst's Orphan Exclusivity Due To Pricing, Not Clinical, Concerns, Firm Claims

Suit against agency reveals internal discussions to approve Jacobus' Ruzurgi despite Catalyst's orphan exclusivity for the same drug; Sen. Bernie Sanders urged FDA to address price of Catalyst's Firdapse (amifampridine).

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