Area of focus

Product Approvals and Dispute Resolution

You want to bring your product to market quickly and efficiently. Anticipating and meeting FDA guidelines and stepping around pitfalls calls for a team that knows the law, the regulatory...

Blog Post

FDA launches temporary “TRIP” program to help HCT/P sponsors gain regulatory clarity

Acting Food and Drug Administration (FDA) Commissioner Ned Sharpless, M.D. recently announced that FDA is implementing a temporary program called the Tissue Reference Group Rapid...

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Hogan Lovells Publications

HHS announces public meeting on ways to accelerate clinical innovation Health Alert

Government seeks industry comment on expediting medical product development

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Blog Post

FDA’s Bendeka decision reverses approvals of Treanda generics

Yesterday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the...

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Hogan Lovells Publications

China drug regulator calling on international pharmaceutical companies to bring “urgently-needed” new drugs to China

On 8 August 2018, in an unprecedented regulatory action, the China National Drug Administration (CNDA) called on international pharmaceutical companies to bring 48 new drugs to China. These ...

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