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Citing the Opioid Abuse Epidemic, New Jersey Proposes Far-Reaching Restrictions on Pharma-Prescriber Interactions

In an effort to curtail the opioid abuse epidemic, New Jersey Governor Chris Christie proposed a new rule on August 31, 2017 that would make New Jersey the latest state to adopt "gift ban" type restrictions on interactions...more

FDA: The Powdered Gloves Come Off

In a rare move, the Food and Drug Administration (FDA) announced on Friday that it is banning the following devices after determining that they present an unreasonable and substantial risk of illness or injury that cannot be...more

FDA Eases Medical Evaluation and Recordkeeping Requirements for Hearing Aids

On Wednesday, the Food and Drug Administration (FDA) released a new guidance document indicating that it will not enforce the medical evaluation and recordkeeping requirements (21 CFR §801.421(a) and (d)) prior to the...more

OIG Guidance on Board Oversight of Compliance Program

On April 20, 2015, the Office of Inspector General in the U.S. Department of Health and Human Services (OIG), together with the Association of Healthcare Internal Auditors (AHIA), the American Health Lawyers Association...more

FDA Attempts to Clarify Enforcement Position Regarding Evolving Health Technology

Recently, the U.S. Food and Drug Administration (FDA) has issued a flurry of guidance and draft guidance in an effort to better define the types of products that the FDA will choose to actively regulate. In one of these...more

CMS Changes Sunshine Rules for CME, Revises List of Data Elements to be Reported

The Centers for Medicare & Medicaid Services (CMS) published a final rule with comment period addressing, among other issues, changes to the reporting and data collection requirements imposed upon “applicable manufacturers”...more

Rules for CME, Revises List of Data Elements to be Reported

Last Friday, the Centers for Medicare & Medicaid Services (CMS) published a final rule with comment period addressing, among other issues, changes to the reporting and data collection requirements imposed upon “applicable...more

Health & Human Services, Office of Inspector General, Proposes New Fraud and Abuse Rules

The U.S. Department of Health & Human Services, Office of Inspector General (OIG) published 79 Fed. Reg. 59717 on October 3, 2014. This proposed rule has the potential to have an impact on a broad array of financial...more

Health Law Alert: OIG Issues Updated Special Advisory Bulletin On The Effect Of Exclusion From Participation In Federal Health...

On May 8, 2013, the U.S. Department of Health and Human Services Office of the Inspector General (OIG) issued an updated Special Advisory Bulletin on the effect of exclusion from participating in federal health care programs....more

Health Law Alert: Final Sunshine Act Regulations Released

On Friday, February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited Sunshine Act regulations. The Sunshine Act requires disclosure of payments and value transfers (Payments) from drug and...more

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