Nearly five decades after the FDA last reorganized animal drug labeling regulations, the agency has released a proposal to revise the requirements for the content and format of labeling for approved ...

A US Supreme Court fight over how branded drugs’ makers must plead induced infringement in “skinny-label” patent suits could ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

One of the greatest achievements in the history of biopharmaceuticals occurred in January 2020, when Pfizer and Moderna used genetic sequencing provided by Chinese laboratories to design mRNA vaccines ...

Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...

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 ...

The Union health and family welfare ministry has come out with Drugs and Cosmetics (Ninth Amendment) Rules, 2019 notifying implementation of new labelling norms for Schedule G, H, H1 and X drugs from ...

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 ...

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 ...

Credit: FDA. Project Renewal is an Oncology Center of Excellence initiative that aims to update the labeling information for certain older oncology drugs. The Food and Drug Administration (FDA) has ...

A new avenue for targeted drug delivery has been proposed by researchers from The Grainger College of Engineering at the University of Illinois Urbana-Champaign. Their findings, published in Materials ...