Jiayan Chen

Jiayan Chen

McDermott Will & Emery

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CMS Proposes Removing CME Exclusion from Sunshine Act Regulations, Citing Redundancy with Indirect Payment Exclusion

In the July 3, 2014, issue of the Federal Register, The Centers for Medicare & Medicaid Services (CMS) published the proposed calendar year 2015 Medicare physician fee schedule update (the Proposed Rule). The Proposed Rule...more

8/8/2014 - Affordable Care Act CMS Continuing Medical Education Medicare Physician Medicare Reimbursements Proposed Regulation Sunshine Act

FDA Issues Draft Guidance on Communications Over Internet and Social Media Platforms

On June 17, 2014, the U.S. Food and Drug Administration (FDA or the Agency) issued two draft guidance documents, providing recommendations for two types of communication over internet and social media platforms. The first...more

7/22/2014 - Advertising FDA Internet Medical Devices Prescription Drugs Social Media

FDA Issues Distribution of Risk Information Draft Guidance Amid Asserted Push to Release Guidance on Manufacturer Communications

The U.S. Food and Drug Administration (FDA or the Agency) issued the June 6, 2014, draft guidance (Draft Guidance) in response to stakeholder inquiries into the Agency’s views on disseminating new scientific or medical...more

6/18/2014 - Draft Guidance Drug Manufacturers FDA Health Safety Pharmaceutical Reporting Requirements

CMS Proposes to Expand Access to Part D Data for Research

On January 10, 2014, the Centers for Medicare and Medicaid Services (CMS) announced a proposed rule to alter key components of the Medicare Advantage (MA) and Part D Programs (Proposed Rule). Understandably, the Proposed Rule...more

3/18/2014 - CMS Medicare Medicare Part D

FDA Releases Final Guidance on “Dear Doctor” Letters That Omits Controversial Behavior Modification Assessment Provision

On January 22, 2014, the FDA issued finalized guidance on the use, content and form of Dear Health Care Provider (DHCP) letters. While the finalized guidance modifies and removes certain controversial provisions from the...more

2/27/2014 - FDA Healthcare Prescription Drugs

Federal Court Vacates Conviction for Truthful Off-Label Promotion of FDA-Approved Drug

In a highly significant decision that may have far-reaching implications for the U.S. Food and Drug Administration’s (FDA) regulatory approach to off-label drug promotion, the U.S. Court of Appeals for the Second Circuit...more

12/11/2012 - FDA Off-Label Promotion Pharmaceutical

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