JD Supra

FDA Proposes to Overhaul Labeling Requirements for Approved or Conditionally Approved New Animal Drugs

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The U.S. Food and Drug Administration (FDA) published new draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software” (PDS Guidance), which describes how FDA intends to ...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

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

Developing standards for the conversion of paper labeling to an electronic format is a high priority for FDA. The content and format revisions to the prescribing ...
STAT

Solicitor general urges Supreme Court to review ‘skinny labeling’ and generic drug access

The U.S. solicitor general urged the U.S. Supreme Court to review a controversy over so-called skinny labels for medicines, arguing that an appeals court finding threatens the availability of ...
The Scientist

Understanding the Drug Development Process

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 ...
Medscape

Reversing Inaccurate Penicillin Allergy Labeling

Accurate labeling of penicillin allergies is essential, but unconfirmed penicillin allergies may have negative effects on individual and public health, according to experts. A trend toward ...