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Theqmnweeklybulletin

Aug. 3, 2012

Vol. 4 No. 31

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EMA Offers Step-by-Step Guidance on New Pharmacovigilance Regs

Drugmakers should have a structured and recognized methodology for assessing evidence in an adverse reaction report, taking into account such factors as clinical relevance, quantitative strength of the association and the exposure-response association, according to a draft European Medicines Agency (EMA) guideline. Read More

New Study May Alleviate Sponsor, Regulator Concerns About Foreign Trials

Drugmakers and regulators can be more confident about the rigor of trial data coming from emerging markets as the quality of studies appears to be on par with trials in more research savvy, developed nations, a new study concludes. Read More

Final PDUFA Package Offers FDA More Supply Chain Security Powers

As House and Senate leaders agreed on a final Prescription Drug User Fee Act (PDUFA) reauthorization package, members of Congress provided the agency with most of the increased supply chain oversight powers it asked for. Read More

FDA Warns IRB for Clinical Trial Without Patients’ Consent

The FDA has warned the IRB at a large Illinois healthcare system for enrolling emergency room patients in a clinical trial without their permission. Read More

ASEAN Draft Medical Device Directive Would Beef Up Adverse Event Reporting

Countries in the Association of Southeast Asian Nations (ASEAN) would have to establish postmarketing surveillance alert systems to report and evaluate device-related adverse events and make the information available to other member states under a draft medical device directive released for comment this summer. Read More

FDA Cites Calif. LapBand Clinic on Misleading Commercials, Billboards

Los Angeles weight-loss surgery clinic Lap-Band VIP has received an FDA warning letter for misleading marketing claims. Read More

Hospira Reports ‘More Issues’ Than Previously Thought, Some Progress in Manufacturing Remediation

Amid lingering quality issues at a number of its manufacturing plants, Hospira reported some success in its discussions with the FDA but notes there are more trouble spots than the company previously thought. Read More

FDA Gives Makers of Unapproved Drugs Last Chance to Request Hearings

The FDA is giving manufacturers of prescription anti-spasmodic, gastrointestinal and hypertension medications that were cited as unapproved drugs decades ago until Aug. 23 to inform the agency if they still want to appeal its decision on the need for an NDA. Read More