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Pharmaceutical Industry › Final Rules › Reporting Requirements

Dinsmore & Shohl LLP

Ohio Board of Pharmacy Takes Aim at Dispensing Errors

Dinsmore & Shohl LLP on

The Ohio Board of Pharmacy (“Board”) published two new rules aimed at preventing and rooting out dispensing errors. The first new rule requires pharmacies to implement quality assurance programs for dispensing errors. The...more

Blake, Cassels & Graydon LLP

Santé Canada propose un règlement visant à atténuer les pénuries de drogues et d’instruments médicaux

Blake, Cassels & Graydon LLP on

Santé Canada a récemment publié un projet de règlement visant à pallier les pénuries de produits thérapeutiques au Canada. Le Règlement modifiant certains règlements pris en vertu de la Loi sur les aliments et drogues...more

McCarter & English, LLP

New Jersey Regulatory Update Part II - February 2025

McCarter & English, LLP on

We continue our New Jersey Regulatory Update with this Part II, which focuses on regulations that were finalized in the second half of 2024 and impact healthcare. For example, as a continuation of price transparency efforts,...more

DLA Piper

FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for...

DLA Piper on

The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting requirements for a nonprescription drug product with an “additional condition for...more

Gardner Law

CMS Auditing Companies for Sunshine Compliance: Are You Ready?

Gardner Law on

As the Sunshine Act reporting deadline of March 31, 2024 draws near, medical device and pharmaceutical companies are gearing up for their Sunshine Act reporting. Are you prepared for a Sunshine Act audit? Reporting...more

Quarles & Brady LLP

New DEA Form 106 Theft & Loss Reporting Deadlines and Submission Requirements

Quarles & Brady LLP on

On June 22, 2023, DEA published a final rule regarding the timing with which registrants are required to report the theft or loss of controlled substances (the “Final Rule”). 88 FR 40707. DEA’s regulations have always...more

Polsinelli

New Clinical Trial Rule Alters Reporting Requirements

Polsinelli on

New federal requirements for posting of clinical trials information address how data collected in clinical trials are submitted for public consumption. The requirements were revealed on Sept. 16 when the Department of Health...more

Stinson LLP

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

Stinson LLP on

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

Mintz - Health Care Viewpoints

CME Payments Largely Remain Excluded From Sunshine Act Reporting

Mintz - Health Care Viewpoints on

The Centers for Medicare & Medicaid Services (“CMS”) has finalized changes to a number of reporting requirements under the regulations implementing the Physician Payments Sunshine Act (“Final Rule”). When CMS proposed...more

Sheppard Mullin Richter & Hampton LLP

Cloudy Skies Ahead for Providers? CMS’ Release of Medicare Billing Data Combined with Physician Payment Sunshine Act Data May...

Sheppard Mullin Richter & Hampton LLP on

In February 2013, we reported (on our Healthcare Law Blog) that the Centers for Medicare and Medicaid Services (CMS) announced the final rule for the Physician Payments Sunshine Act. In the interest of providing more...more

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