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Reporting Requirements Pharmaceutical Industry Biologics

Smart & Biggar

2020 Highlights in Canadian Life Sciences IP and Regulatory Law

Smart & Biggar on

In 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: Table of Contents 1. COVID-19: CIPO, Federal Courts, Health Canada 2. PMPRB:...more

Goodwin

Q3 2020 Earnings Roundup: Biologics and Biosimilars Update

Goodwin on

Below are some highlights from third quarter 2020 earnings reports recently released by biologics and biosimilars companies: ..Biogen reported a decrease in year over year (YoY) revenue of 6% to $3.4 billion, but a 13%...more

K&L Gates LLP

K&L Gates Triage: Q&A: What Sponsors and Investigators Need to Know about FDA’s ClinicalTrials.gov Reporting Requirements

K&L Gates LLP on

FDA’s recent release of new guidance on civil money penalties for the failure to submit required information to the ClinicalTrials.gov data bank may indicate a renewed interest in the enforcement of these requirements. On...more

American Conference Institute (ACI)

[Event] FDA BOOT CAMP - March 25 - 27, 2019, New York, NY

Obtain the guidance you need to master the difficult area of FDA regulatory law - For over 15 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of...more

Faegre Drinker Biddle & Reath LLP

Biologic and Biosimilar Settlement Agreements Now Must Be Disclosed to DOJ and FTC

Recent amendments to the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), titled the Patient Right to Know Drug Prices Act, require parties to inform regulatory authorities of executed settlement...more

Perkins Coie

CMS Issues Final Physician Payment Sunshine Act Regulations

Perkins Coie on

On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations implementing the Physician Payment Sunshine Act (Act or Sunshine Act). The Sunshine Act requires drug,...more

BakerHostetler

Physician Payment Sunshine Rule Finalized; Let The Sun Shine In; Payment Reports Flow

BakerHostetler on

The Centers for Medicare and Medicaid Services (CMS) recently published the final rule implementing the Physician Payment Sunshine Act (Sunshine Act) that requires most manufacturers of drugs, devices, biologics or medical...more

Mintz - Health Care Viewpoints

Let the Collection and Reporting Begin: CMS Publishes Final Sunshine Act Regulations

The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register. It amends key definitions and adds new terms; retains broad reporting...more

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