OKLAHOMA CITY (AP) - A federal agency approved a new label for a common abortion-inducing drug that will undermine restrictions on medication abortions passed by several states, allowing women to take ...
The federal government re-ignited a controversial proposal to give generic drug makers the power to unilaterally update product labels to reflect new safety information, a proposal that drew criticism ...
Medications once used to treat illness are increasingly being taken for prevention. Experts explain what’s behind the ...
Feb. 14—CONCORD — A key House committee embraced Monday protections for health care providers who prescribe off-label prescription drugs for their patients. This campaign for reform started after ...
America is in the midst of a pharmacy crisis, and the Food and Drug Administration could make it much worse. Hundreds of ...
On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) ...
The Skinny Labels, Big Savings Act was introduced on January 9 in an effort to provide “a statutory safe harbor from patent ...
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 ...
FDA’s recent draft guidance, Regulatory Considerations for Prescription Drug Use Related Software, proposes a regulatory framework for software disseminated by a drug sponsor that supplements or ...
Every day in medical offices around the country, physicians hand patients prescriptions for drugs to treat conditions for which the medicines haven't been approved. Once a drug is approved by the Food ...