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The FDA is taking some initial steps to see if the growing use of IT in the healthcare system — including through electronic prescribing and electronic medical records — could boost its ability to monitor drug safety.
The growing use of IT in the healthcare system — including through electronic prescribing and electronic medical records — could significantly boost the FDA’s ability to monitor drug safety, according to a top agency official.
Acting FDA Commissioner Lester Crawford believes the science is available for the FDA to move forward on follow-on biologic products, but he told a recent industry conference that the FDA still has many kinks to work out on the regulatory front.
Cincinnati Sub-Zero Products was issued a warning letter by the FDA after an agency inspection revealed the company’s class II hypothermic/ hyperthermic machines to be adulterated within the meaning of Section 501(h) of the Federal Food, Drug and Cosmetic Act (FDCA) and for violations of the quality system (QS) regulation.
FDA drug safety reviewers should have a new data mining tool this spring to help them evaluate the hundreds of thousands of reports submitted annually to the Adverse Events Reporting System (AERS) — a system that is now more widely available to the public online.
A “suspicious” string of citizen petitions is deliberately blocking Noven Pharmaceuticals’ efforts to bring a generic version of Johnson & Johnson’s (J&J) Duragesic transdermal pain patch to market, Noven claimed in a recent FDA filing.
The FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) has issued an untitled letter to Schering informing the company of misleading information it published recently in a professional detail aid promoting the use of Foradil Aerolizer 12 mcg.
AstraZeneca has received a letter from the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) citing the firm’s safety claims for its cholesterol-lowering drug Crestor, which the agency has deemed false and misleading.
Although the FDA is still working out the details, agency officials expect electronic labeling to play a key role in the future of healthcare technology initiatives.