FDA describes unprecedented new efforts to support development of over-the-counter naloxone to help reduce opioid overdose deaths

FDA approved the first generic version of Sabril for treating complex partial seizures, as an adjunctive therapy in certain patients.

FDA describes new policies to advance development of safe and effective cell and gene therapies

FDA issues three documents that launch next phase of Pre-Cert Pilot Program to test new approaches for the review of digital health device applications.

The FDA authorized use of a new test that measures nutrients in breast milk providing healthcare professionals with tool to aid in the nutritional management of newborns.

The FDA approved Ultomiris (ravulizumab) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disease.

The FDA approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older.

Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds

The FDA provides update on Essure postmarket review study as company prepares to halt sales of the device on December 31.

FDA alerted parents, caregivers and health care providers to the safety risks that jewelry used for relieving teething pain pose for children.

FDA sends warning letter to Genetech, Inc. and letters to other companies to reiterate the FDA’s compliance and enforcement policy regarding stem cells.

FDA announces steps being taken on two medical device programs: finalizing guidance on the Breakthrough Device Program and announcing plans for a new Safer Technologies Program (STeP).

FDA’s 2017 report of sales/distribution data for antimicrobial drugs for food animals showed a continued decline in sales, a reflection of improved antimicrobial stewardship

Saranac Brand Foods, Inc. specialized in a variety of 35 different ready-to-eat foods, including prepared salads, dips, and sauces.

Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas on new findings and updated consumer recommendations related to the romaine lettuce E. coli O157:H7 outbreak investigation

FDA announces withdrawal of the proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

FDA releases guidance with recommendations for drug manufacturers regarding good manufacturing practices and data integrity

FDA update on the ongoing investigation into angiotensin II receptor blocker impurities, recalls and current findings.

FDA announces new actions advancing the agency’s biosimilars policy framework

FDA provides updates to postmarketing studies that agency ordered three manufacturers of duodenoscopes to conduct to assess bacterial contamination of devices.