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Applicable Manufacturers Pharmaceutical Industry

Seyfarth Shaw LLP

FDA Announces the Creation of CTAP—Coronavirus Treatment Acceleration Program—to Assist Drug Developers and Evaluators

Seyfarth Shaw LLP on

The US Food and Drug Administration (FDA) is prioritizing the development and review of new therapies to treat COVID-19 through a recently created special emergency program titled Coronavirus Treatment Acceleration Program...more

Kramer Levin Naftalis & Frankel LLP

Biosimilar Litigation Trends and Lessons Learned in 2019

It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more

Hogan Lovells

CAMD released roadmap concerning the priorities for the implementation of the MDR and IVDR

Hogan Lovells on

The Competent Authorities for Medical Devices (“CAMD”) has published a roadmap concerning the implementation of the Medical Devices Regulation (“MDR”) and In Vitro Diagnostic Regulation (“IVDR”). The roadmap has been prepared...more

Bradley Arant Boult Cummings LLP

The Sunshine Act Final Rule: CMS Sheds Light on Reporting Physician and Teaching Hospital Payments

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released a final rule implementing the Physician Payment Sunshine Act (the “Act”). The Act requires certain manufacturers of covered drugs, devices, and...more

Baker Donelson

Physician Payment Sunshine Rule is Finalized

Baker Donelson on

The Final Rule implementing the Physician Payment Sunshine Act was announced on February 1st and published in the Federal Register on February 8th. The Final Rule establishes procedures for drug and device manufacturers to...more

Wilson Sonsini Goodrich & Rosati

CMS Issues Final Rule for Implementing Sunshine Act

On February 8, 2013, 16 months after the statutory deadline, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register the final regulation implementing the physician payment transparency...more

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