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Pharmaceutical Industry › BPCI

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Issues Final and Draft Guidances on Biosimilar Development under BPCIA

McDonnell Boehnen Hulbert & Berghoff LLP on

In September, the U.S. Food and Drug Administration issued Final Guidance entitled "Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry," and Draft Guidance entitled "New and Revised Draft...more

Patterson Belknap Webb & Tyler LLP

FDA’s Draft Guidance for Industry Seeks to Answer Questions on Biosimilar Interchangeability

Patterson Belknap Webb & Tyler LLP on

FDA has published new draft guidance for industry titled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act.” ...more

BakerHostetler

FDA Alerts Compounders of a Major Change in Practice

BakerHostetler on

With just days remaining until the “Deemed to Be a License” transition takes effect, the FDA issued an unexpected sweeping change to compounding practice. ...more

Foley & Lardner LLP

Orthopedics: The New Darling of Private Equity

Foley & Lardner LLP on

The past decade has seen a tremendous amount of private equity investment in physician practice recapitalizations, primarily in hospital-based practices such as anesthesiology and radiology as well as “retail medicine...more

BakerHostetler

A Step Forward in Approving Lower-Cost “Generic” Biologic Drugs

BakerHostetler on

A federal advisory panel has helped clear the path for what may be the first biosimilar biologic drug ever approved in the United States. Interestingly, generics of traditional drugs have been available in the U.S. for...more

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