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Drug sponsors may not have to prove that a proposed medicine-assisted therapy helps addicts completely kick opioids but they will have to detail how well it helps cut dependence to win FDA approval, the agency says in a new draft guidance released Monday. Read More
The terms of the 2008 deal between Allergan, then called Actavis, and King required King to indemnify any damages relating to marketing of Kadian before 2009. Read More
Drug sponsors and investigators should work with organizations that offer either interoperable or integrated electronic health records or electronic data capture systems, the FDA said in a final guidance. Read More
The FDA released draft guidance on field alert reports, using a Q&A format to outline the responsibilities of drug applicants for FAR submissions. Read More
The FDA released draft guidance outlining the information sponsors should include on the Indications and Usage section of drug and biologics labeling. Read More
The FDA announced that it will take enforcement action against compounders using the unapproved bulk substance cesium chloride, partially granting a December 2017 petition by Public Citizen. Read More
CDER Director Janet Woodcock announced details of two new voluntary programs designed to support improvements in product and process quality and to enhance the agency’s use of quality metrics. Read More
In the wake of hundreds of healthcare fraud arrests by the Justice Department last week, FDA Commissioner Scott Gottlieb promised more inspections of compounding and outsourcing facilities that distribute products without a valid medical need. Read More