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24 Total results for product and free and sample content found

Pink Sheet

New Leader & Reorgs at Key Regulatory Agencies

New leaders and 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

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

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

Australian Bodies Set Out Joint Position On Coronavirus

Australian-Bodies-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

Stress Test: Coronavirus Challenges China Emergency Approval Mechanism

Beijing_returntowork

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

UK Firms Asked To Check Coronavirus Supply Chain Impact

Supply

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

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

FDA Emails

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).

HBW Insight

No Plans To Remove CBD Products From Shelves, Says UK Food Regulator

No_Plans_To_Remove_CBD_Products_1

CBD products already on the UK market are safe for now, as the country's Food Standards Agency says it will not take action while it works out how to implement the new European Union novel food regulations. 

Pink Sheet

EU Countries Test Offering Simultaneous Scientific Advice

EU_Countries_Test_Offering

An EU pilot project will assess whether there is sufficient demand from companies to obtain simultaneous scientific advice from EU national competent authorities.

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