The FDA has expanded the new Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) to include immediate release opioids. The program, which also includes extended release and long acting opioids, will provide education to prescribers and healthcare professionals…
FDA Sets Stricter Requirements for Immediate-Release Opioids to Prevent Misuse & Abuse
The FDA is expanding its Risk Evaluation and Mitigation Strategy (REMS) to include manufacturers of immediate-release opioids. The makers of these drugs will soon be required to provide training and education to healthcare professionals on the proper prescription and use of the drugs for pain management…
U.S. House Panel Spotlights Use of FDA Rules to Slow Generic Drugs
WASHINGTON (Reuters)—Republican and Democratic lawmakers on Thursday discussed ways to prevent drugmakers from using rules developed to safeguard patients to instead block the sale of cheaper medicines. The focus at a hearing, held by members of the House Judiciary Committee’s antitrust subcommittee, was on the use by some brand name drug companies of a U.S….
Abaloparatide-SC May Reduce Fractures for Osteoporosis & New FDA Safety Website
In a 25 month Phase 3 trial, abaloparatide-SC reduced the risk of new fractures in patients suffering from postmenopausal osteoporosis. Plus, the FDA launches a new drug safety website.
REMS Required
How will this FDA drug safety program affect rheumatology offices?