It's the Law

The legal arm of the regulatory profession is fluid and changing. These articles attempt to explain some of the nuances of regulatory law and what should be considered when making decisions.

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1 August 2013

Document Authentication for Product Registration/Regulatory Submissions Outside the US

By Fritz Ahlers

It’s important to know that when engaged in marketing its medical devices, IVDs, pharmaceutical products, cosmetics or foods in other countries, your company will be required to have certain regulatory, quality or supporting technical documents authenticated either by apostille (French for “certification”) or by consular legalization through the embassy of the target country. So what does legalization, or more properly, consular legalization, or alternatively, apostille mean? More importantly, why is it essential? [Read More...]

18 June 2013

Sunshine Act Reporting: Research Payments and Requests for Delayed Publication

By Jane Wright-Mitchell, PharmD, JD

On 8 February 2013, the US Centers for Medicare and Medicaid Services (CMS) issued its final rule on the reporting requirements for certain payments and other transfers of value under the Patient Protection and Affordable Care Act (PPACA), commonly referred to as the Physician Payment Sunshine Act (Sunshine Act). This article focuses specifically on the issue of research and development-related payments. [Read More...]

23 July 2012

Orange Book Listings Lesson: An overly broad use code may lead to legal challenges

By Jane Wright-Mitchell, PharmD, JD

The US Supreme Court's recent Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S decision highlights the different viewpoints of the courts in the pharmaceutical arena, in particular drawing attention to the interaction of pharmaceutical patents to the US Food and Drug Administration (FDA)-generated Orange Book. [Read More...]

1 December 2011

Considerations in View of the New US First-Inventor-to-File Patent System

By Shahnam Sharareh, PharmD, RAC, and Sarah Klosek, MS

The US patent system has a rendezvous with change. On 16 March 2013, it will officially change from a first-to-invent to a first-inventor-to-file system as authorized by the Leahy-Smith America Invents Act.

Under the current first-to-invent system, a patent is awarded to the inventive entity that invents first. In contrast, under a first-inventor-to-file system, a patent is awarded to the inventive entity that is the first one to file a patent application on its own invention.

[Read More...]

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