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Health Care Providers › Medical Devices › Disclosure Requirements

McCarter & English, LLP

FDA Finalizes Guidance on Communications Regarding Unapproved Uses of Medical Products

McCarter & English, LLP on

In January 2025, the US Food and Drug Administration (FDA) finalized its 2023 revised draft guidance Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

Gardner Law

Sunshine Act Compliance: How to Take Action to Meet Reporting Requirements and Avoid Costly Penalties

Gardner Law on

The clock is ticking for medical device and pharmaceutical companies to fulfill their obligations under the Physician Payments Sunshine Act (the "Sunshine Act"). With the reporting deadline of March 31 looming and CMS...more

Goodwin

How to (Finally) Get Your SIUU Out: FDA Issues Final Guidance on Communicating Off-Label Scientific Information

Goodwin on

On January 7, 2025, FDA announced the availability of a final guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more

Gardner Law

Navigating HIPAA and State Privacy Laws for Drug and Device Manufacturers

Gardner Law on

The Health Insurance Portability and Accountability Act of 1996 as amended and implemented through regulations at 45 C.F.R. §§ 160 and 164 (“HIPAA”) regulates the privacy and security of health information. For drug and...more

Mintz - Health Care Viewpoints

Connecticut Law Imposes New Requirements on Pharmaceutical Manufacturers, Defined to Include Device and Cosmetic Manufacturers,...

Mintz - Health Care Viewpoints on

Public Act No. 23-171: An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs (Act) took effect in Connecticut on October 1, 2023. Under the Act, a pharmaceutical manufacturer (PM) that employs...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Health Care Compliance Association (HCCA) on

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Akin Gump Strauss Hauer & Feld LLP

CMS Issues Proposed Revisions to Open Payments/Sunshine Act Reporting Requirements

Akin Gump Strauss Hauer & Feld LLP on

• On July 29, 2019, CMS released its proposed 2020 Physician Fee Schedule rule, which includes the much anticipated proposed regulatory changes to the Sunshine Act/Open Payments program (“Open Payments”). The proposed...more

Smart & Biggar

Rx IP Update - December 2017

Smart & Biggar on

PMPRB News - PMPRB releases scoping paper relating to proposed amended Regulations - As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented...more

Cooley LLP

Blog: On a Roll . . . Vermont Attorney General Posts Two More Enforcement Actions for Gift Ban & Disclosure Law

Cooley LLP on

The Vermont Attorney General (VT AG) posted its third round of enforcement actions of 2015 against a manufacturer of surgical microscopes and a dental products company....more

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