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Wisconsin Gov. Jim Doyle should issue an additional disclaimer that drugs purchased through his state's reimportation website are not necessarily approved by U.S. regulators and may be unsafe, a top FDA official told the governor.
The Center for Biologics Evaluation and Research (CBER) has released details about the action plan it will implement when responding to reports of counterfeit drugs.
The FDA and the HHS Task Force on Drug Importation will convene a public meeting April 14 for industry, the public and other stakeholders to submit comments and information for a study on the feasibility of importing prescription drugs from Canada.
Drug industry representatives are blasting an FDA proposal that would require drugmakers to collect race and ethnicity data for postmarket adverse event reports (AERs), claiming that the requirement would impede reporting efforts and be of little scientific value.
To help lighten the paperwork load associated with product safety information requests, the FDA is encouraging drugmakers to use summary bridging reports (SBRs) when regulatory authorities seek safety data spanning beyond a single periodic safety update report (PSUR).
Wisconsin joined Minnesota yesterday as a leading Rx drug reimportation proponent by expanding the state’s official website to include pricing data and ordering information for residents to buy prescription drugs from state-recommended Canadian pharmacies.
The FDA has ignored pleas from PhRMA to implement paper pedigree requirements in the Prescription Drug Marketing Act of 1987 (PDMA) immediately, announcing it will continue to stay the requirements for another 32 months while it oversees industry’s adoption of electronic pedigrees using track-and-trace technologies.
Adding race and ethnicity reporting requirements to FDA MedWatch forms is liable to impede companies’ postmarket adverse event reporting efforts and be of little scientific value, according to comments recently submitted to the agency.
Continuing its enforcement efforts against companies that facilitate drug reimportation, the FDA issued a warning letter Wednesday to a West Virginia storefront operation it accused of violating federal law by working with a Canadian internet pharmacy to import lower-cost Rx drugs into the U.S.
The FDA has shut down four websites it claims sold bogus transdermal contraceptive patches containing no active ingredient in its ongoing enforcement efforts against drug counterfeiters, the agency said Feb. 12.