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Pharmaceutical Industry › Food and Drug Administration (FDA) › Amended Regulation

Foley & Lardner LLP

FDA’s Final Rule on Direct-to-Consumer Advertising – Presentation of Risk Information

Foley & Lardner LLP on

In November 2023, the U.S. Food and Drug Administration (FDA) published its final rule (Rule) to amend its regulations concerning radio and television direct-to-consumer (DTC) advertisements (ads) for human prescription drugs...more

Smart & Biggar

2019 Mid-Year Highlights in Canadian Life Sciences IP

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Below are the major highlights in Canadian life sciences intellectual property and regulatory law that we have reported on in the first half of 2019....more

Smart & Biggar

Proposed Amendments to Food and Drug Regulations: Generic drug equivalence, labeling, and related terminology

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Health Canada released proposed Regulations Amending the Food and Drug Regulations (Improving Access to Generics) (“proposed Regulations”) on March 30, 2019. Comments may be submitted until June 8, 2019....more

Mintz - Health Care Viewpoints

How to Safely and Productively Promote an FDA-Regulated Medical Product

Mintz - Health Care Viewpoints on

As any medical product business knows, compliance with the AdvaMed Code of Ethics (the “Code”) is essential. While the Code is voluntary, many states require medical product manufacturers and companies to adopt compliance...more

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