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A recent discussion paper issued by Health Canada proposes a new system of “progressive” licensing of prescription drugs to improve information on safety and efficacy after they are approved for use.
South Africa’s Medicines Control Council (MCC) recently implemented final guidance on the submission of post-registration amendments concerning medicines and changes to facilities, including change of manufacturer or holder of the certificate of registration.
Rep. Rosa DeLauro (D-Conn.), a frequent critic of the FDA’s drug safety system, has seized on a recent agency report as evidence that the agency’s postmarketing efforts are failing, but industry and activists are skeptical of her reasoning.
Clinical research information should be included in the Nationwide Health Information Network (NHIN) to enable faster discovery and assessment of cures and treatments, according to a recent report from the nonprofit FasterCures.
Clinical research information should be included in the Nationwide Health Information Network (NHIN) to enable faster discovery and assessment of cures and treatments, according to a report from nonprofit FasterCures.
The key to success in postmarketing trials is motivating sites and investigators properly, Hugo Stephenson, president of Strategic Research and Safety at Quintiles, said in a recent FDAnews audioconference.
The U.S. Food and Drug Administration (FDA) should be given the authority to impose severe punishments on drug manufacturers who dont live up to their postmarketing commitments, according to an Institute of Medicine (IOM) report that offers a harsh assessment of the agencys current drug safety efforts.
Peru’s Ministry of Health has issued proposed rules covering the manufacture, production, control, postmarket surveillance, import and export of pharmaceutical and biological products.
The FDA is opposing substantive changes to its postmarketing policies despite a recent HHS Office of Inspector General (OIG) finding that the agency does not take its postmarketing review responsibilities seriously enough.