RAPS

FDA releases guidance on labeling of drug use-related software outputs

The US Food and Drug Administration (FDA) has released draft guidance with considerations on how to include software outputs of drug use-related software in prescription labeling. In the draft ...
RAPS

FDA issues guidance documents on labeling drug identity, constituents

The US Food and Drug Administration (FDA) has issued two draft guidance documents aimed at improving the consistency of labeling for both over-the-counter (OTC) and prescription drugs. One of the ...
JD Supra

FDA Releases Draft Labeling Guidance for Biosimilar Products

Last week, FDA released a draft guidance, “Labeling for Biosimilar and Interchangeable Biosimilar Products” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final ...
JD Supra

U.S. FDA: labeling guidance for sponsors incorporating prescription drug use-related software

The U.S. Food and Drug Administration (FDA) published new draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software” (PDS Guidance), which describes how FDA intends to ...
MM&M

FDA’s updated RWE guidelines allow pharma marketers to make more claims

Prevailing regulations state that only “on-label” claims may be used by manufacturers in pharma advertising. A draft guidance released this week by the Food and Drug Administration, provides an ...
The National Law Review

“Dietary Guidance Statements” in Food Labeling: What You Need to Know About FDA’s Latest Draft Guidance for the Food Industry

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

Americans Are Reading The Nutrition Label — And Seeking A Balanced Approach To Front-of-Package Labeling Guidance

The survey found that 79% of Americans check nutrition or ingredient information on packaging at least sometimes while grocery shopping. Nearly half (47%) do so always or often. Confidence is ...