Publications

Hogan Lovells Publications

U.S. Supreme Court rules judges must decide whether preemption applies, and clarifies when it does Pharmaceuticals and Biotechnology Alert

Opinion highlights importance of a "clear" record at FDA

Hogan Lovells Publications

FDA guidance may ease path to biosimilar interchangeability Focus On Regulation

On 10 May 2019 the U.S. Food and Drug Administration (FDA) published the final guidance, "Considerations in Demonstrating Interchangeability With a Reference Product," which is intended to...

Hogan Lovells Publications

FDA publishes final guidance on ANDA/505(b)(2) NDA pathways Focus On Regulation

On 9 May 2019 the U.S. Food and Drug Administration (FDA) published the final guidance document, "Determining Whether to Submit an ANDA or a 505(b)(2) Application," that contains minor...

Hogan Lovells Publications

China adds 30 drugs to its "urgently needed" list Pharmaceutical and Biotechnology Alert

Faster review periods and waiver of requirement for Chinese clinical trials are intended to encourage marketing applications

Hogan Lovells Publications

FDA's Bendeka decision reverses approvals of Treanda generics Focus On Regulation

On 20 February 2019 the U.S. Food and Drug Administration (FDA) released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle...

Hogan Lovells Publications

Would you like an extra application with that? FDA mulls requiring dual applications for combination products Focus On Regulation

On Tuesday, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance, "Principles of Premarket Pathways for Combination Products," with high-level...

News

Pharma Companies May Benefit from Proposed Patent Law Changes in China; Public Comment Invited

On January 4, China’s National People’s Congress (NPC) released draft amendments to the Chinese Patent Law, proposing expanded and enhanced protections that may provide real...

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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