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Food and Drug Administration (FDA) › Combination Products

Snell & Wilmer

FDA publishes manual on complex product classification for generic development

Snell & Wilmer on

The US Food and Drug Administration (FDA) recently published a manual of policies and procedures (MAPP) outlining how the Office of Generic Drugs (OGD) will classify which new drugs and drug-device combination products are...more

Hogan Lovells

Final FDA combination product guidance encourages application-based feedback pathways

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently finalized its guidance entitled “Requesting Food and Drug Administration Feedback on Combination Products,” stressing as it did in the draft version that “application-based...more

Smart & Biggar

Project Orbis enables concurrent regulatory approval of LENVIMA and KEYTRUDA combination therapy in Canada, U.S. and Australia

Smart & Biggar on

On September 17, 2019, the combination therapy of Eisai’s LENVIMA (lenvatinib) and Merck’s KEYTRUDA (pembrolizumab) for the treatment of advanced endometrial carcinoma received simultaneous approvals by Health Canada, the...more

Hogan Lovells

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

Hogan Lovells on

On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level information on ways to bring combination products to market....more

Foley & Lardner LLP

FDA to Give 5 Year NCE Exclusivity to Combinations

Foley & Lardner LLP on

In a Federal Register Notice dated February 24, 2014, the U.S. FDA announced a draft guidance for industry that will provide a 5 year NCE exclusivity period to fixed-combination drug products that include at least one new...more

McDonnell Boehnen Hulbert & Berghoff LLP

Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. (Fed. Cir. 2013)

McDonnell Boehnen Hulbert & Berghoff LLP on

When is a combination of two separate treatments for a particular disease obvious-to-try, such that it is rendered obvious for the purposes of patentability? The Supreme Court answered this question in KSR Int'l Co. v....more

King & Spalding

FDA Issues Final Rule Regarding CGMPs for Combination Products

King & Spalding on

On Tuesday, January 22, 2013, the United States Food and Drug Administration (FDA or “the Agency”) published a final rule regarding Current Good Manufacturing Practice Requirements for Combination Products. 78 Fed. Reg. 4307...more

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