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In saying it will file suit in federal court against the FDA over the issue of importing Rx drugs from Canada, Vermont becomes the first state in the nation to sue the agency for blocking an importation proposal.
Boston is the latest municipality encouraging the importation of prescription drugs to receive a warning from the FDA about the dangers such programs can create for consumers.
The brand industry is urging the FDA to strengthen standards for FDC HIV/AIDS drugs, even as the FDA moves forward with approving the first once-daily fixed-dose combination (FDC) products and a leading generic FDC AIDS drug producer faces concerns about its products’ bioequivalency standards.
The FDA has announced name and address changes for a pair of divisions within the Center for Drug Evaluation and Research’s (CDER’s) Office of Compliance.
A link between antidepressant use and suicide in pediatric patients, first disclosed by an FDA scientist, appears to have been proven, according to the former director of the National Institute of Mental Health.
Rep. Maurice Hinchey (D-N.Y.) is challenging the claim by five former FDA chief counsels that a legal precedent has been established for unsolicited agency intervention on behalf of drugmakers in product liability suits.
Two influential senators are close to an agreement on provisions to a bill that would require manufacturers to report serious adverse events (AEs) associated with dietary supplements and conduct premarket testing of dietary stimulants, according to a spokesman for Sen. Richard Durbin (D-Ill.), a chief sponsor of the measure.
Vermont officials say they will file suit in federal court against the FDA over the issue of importing Rx drugs from Canada, making the state the first in the nation to sue the agency for blocking an importation proposal.