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The US Food and Drug Administration (FDA) has released a new draft guidance describing what should and should not be included in the Drug Interactions (DIs) section for human prescription drug and ...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

Supreme Court takes up generic drug labeling fight

Supreme Court justices on Wednesday will hear arguments in a patent case that could change the way generic drug companies ...
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 ...
Stocktwits on MSN

MLTX stock soars overnight after FDA backs skin drug filing — analyst sees over 300% upside on 'best-in-class' label

MoonLake said that the FDA agreed to include results from both the Phase 2 Mira study and Phase 3 Vela trials in the proposed drug label. ・Clear Street maintained a ‘Buy’ rating and $70 price target ...
JD Supra

FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software

On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) ...
RAPS

FDA Moves Forward With Drug Labeling Revision Project

The US Food and Drug Administration (FDA) is out with new information about an initiative first announced in 2013 that is meant to convert the labeling of hundreds of older drugs into a newer and ...
Cure Today

The FDA Approves Labeling Update for Sandoz in the Treatment of B-Cell CLL

Project Renewal updates older oncology drug labels to ensure clinical relevance and scientific accuracy, involving external experts and early-career scientists. Fludarabine phosphate's updated label ...
Law

The Big Impact of Skinny Labels: What the Supreme Court’s Decision in 'Hikma v. Amarin' May Mean for Patent Strategy

The Supreme Court will decide if a generic drug maker that omits patented uses from its label can still be liable for patent infringement based on marketing. The ruling could impact pharmaceutical ...
MedPage Today

Growing Controversy Over 'Skinny' Labeling for Generic Drugs

The vast majority of patients who initiated imatinib therapy for gastrointestinal stromal tumors (GISTs) received a generic drug that did not have FDA approval for that indication, a large ...