High Court’s ‘Skinny Label’ Ruling Boosts Patent Case Defenses

The US Supreme Court’s recent ruling protecting generic-drug “skinny labels” has the potential to give technology, ...
WTOP News

How to Read an OTC Medication Label: Your Guide to the Drug Facts Box

It may seem simple: You’re feeling miserable from being under the weather with the flu, so you go to your nearest drugstore to pick up over-the-counter cold and flu medicine to give you some relief ...
Hosted on MSN

FDA labeling rules aim to cut medication risks

Clear format rules: The FDA mandates a consistent label structure to ensure providers can quickly locate critical drug information. Patient safety focus: Medication Guides are required for certain ...

Supreme Court Protects ‘Skinny Label’ Generic Drug Pathway (2)

The Supreme Court said a district court judge was right to dismiss Amarin Pharma Inc.'s infringement suit over claims its ...
RAPS

FDA drafts guidance on drug interaction labeling

The US Food and Drug Administration (FDA) has released a new draft guidance describing what should and should not be included in the Drug Interactions (DIs) section for human prescription drug and ...
RAPS

FDA Issues New Drug Labeling Recommendations Intended to Avoid Medication Errors

The US Food and Drug Administration (FDA) has released a new draft guidance for industry recommending changes to the way companies place safety information on container labels and cartons, saying the ...
Medical Xpress

FDA to revise labeling of ADHD medication to indicate weight loss risk

Extended-release stimulants are currently not approved for children younger than 6 years, but health care professionals do prescribe them "off label" to treat ADHD. Clinical trials have shown that ...
JD Supra

FDA proposes mandatory patient labeling for Rx drugs - Proposed Patient Medication Information (PMI) is the latest in many efforts by FDA to mandate patient-directed labeling

Last week, the U.S. Food and Drug Administration (FDA) published the proposed rule “Medication Guides: Patient Medication Information,” which would significantly change the agency’s prescription drug ...
Medscape

Introduction to the New Prescription Drug Labeling by the Food and Drug Administration

A label begins with highlights, a succinct, half-page summary of the information that health care practitioners most commonly refer to and view as most important (Figure 2). [4] This section provides ...
CNN

FDA updates Ozempic label to acknowledge some users’ reports of blocked intestines

The US Food and Drug Administration has updated the label of the diabetes drug Ozempic to acknowledge reports of blocked intestines in some people using the medication. Ozempic and its sister drug, ...