Brazil Moves to Streamline GMP Certificates, International StandardsThe prospect of a standardized single audit program for medical devices, currently being developed by the International Medical Device Regulators Forum, is fueling efforts by Brazil’s Anvisa to bring device good manufacturing practice regulations in line with international standards, an expert says. Read More
Quest, Hologic Sign Five-Year Deal on Women’s DiagnosticsHologic and Quest Diagnostics have struck a five-year deal for Quest to offer a broader range of women’s health testing based on Hologic’s APTIMA products. Read More
Industry, Patient Advocates Spar Over Need for 510(k)s for ModificationsIndustry’s case against significant reforms to the FDA’s policy on when devicemakers must submit a new 510(k), made during a Thursday public meeting, drew pushback from consumer groups that argued current controls don’t ensure patient safety. Read More
China Beefs Up Controls of IVD Reagents; Buyers Should Monitor for ComplianceThe China Food and Drug Administration last month released a document outlining acceptance criteria for in vitro diagnostic reagents makers. Read More
FDA: Devicemakers Should Consider Hacking Risks During Device DesignPremarket submissions for internet-connected medical devices should include cybersecurity risks considered during the product design, established cybersecurity controls and a traceability matrix linking the controls to the risks they mitigate, according to a draft guidance. Read More
EU Device Regulations: Little Support for PMA; Mandatory Liability Coverage ProposedEU lawmakers seemed lukewarm, at best, on the idea of subjecting the riskiest medical devices to a U.S.-style premarket approval mechanism during a May 29 debate by members of the Committee on the Environment, Public Health and Food Safety. Read More
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Brazil Moves to Streamline GMP Certificates, International StandardsThe prospect of a standardized single audit program for medical devices, currently being developed by the International Medical Device Regulators Forum, is fueling efforts by Brazil’s Anvisa to bring device good manufacturing practice regulations in line with international standards, an expert says. Read More
Quest, Hologic Sign Five-Year Deal on Women’s DiagnosticsHologic and Quest Diagnostics have struck a five-year deal for Quest to offer a broader range of women’s health testing based on Hologic’s APTIMA products. Read More
Industry, Patient Advocates Spar Over Need for 510(k)s for ModificationsIndustry’s case against significant reforms to the FDA’s policy on when devicemakers must submit a new 510(k), made during a Thursday public meeting, drew pushback from consumer groups that argued current controls don’t ensure patient safety. Read More
China Beefs Up Controls of IVD Reagents; Buyers Should Monitor for ComplianceThe China Food and Drug Administration last month released a document outlining acceptance criteria for in vitro diagnostic reagents makers. Read More
FDA: Devicemakers Should Consider Hacking Risks During Device DesignPremarket submissions for internet-connected medical devices should include cybersecurity risks considered during the product design, established cybersecurity controls and a traceability matrix linking the controls to the risks they mitigate, according to a draft guidance. Read More
EU Device Regulations: Little Support for PMA; Mandatory Liability Coverage ProposedEU lawmakers seemed lukewarm, at best, on the idea of subjecting the riskiest medical devices to a U.S.-style premarket approval mechanism during a May 29 debate by members of the Committee on the Environment, Public Health and Food Safety. Read More
India Intensifies Site Inspections in Response to Infant DeathsThe Drugs Controller General of India (DCGI) is increasing inspections of clinical trial sites rather than imposing new regulations in the wake of two recent incidents in which infants died in studies sponsored by multinational drug companies. Read More
State Bills Advocate Bans, Reporting for Drugmaker GiftsThe Vermont legislature has sent a bill to the governor to sign, which would ban all gifts from manufacturers of prescription drugs, devices and biologics to doctors, nonprofits, healthcare organizations and state-funded schools. Read More
AstraZeneca’s Brilinta Beats BMS’ Plavix in Clinical TrialAstraZeneca’s investigational oral antiplatelet drug Brilinta was more effective than Bristol-Myers Squibb’s blood-thinner Plavix in preventing cardiovascular events in patients with acute coronary syndromes (ACS) in a Phase III clinical trial. Read More
Scientific Protein Laboratories Gets Form 483 for Heparin PlantThere were several incidents in which personnel at Scientific Protein Laboratories signed off on incorrect or inadequate data and reports, calling into question the company’s management review of production operations, according to a recent FDA Form 483. Read More
FDA Estimates Annual IND Safety Reports at 25,000Safety and adverse event reporting take up the majority of time clinical trial sponsors and investigators devote to reporting and recordkeeping related to IND regulations each year, FDA figures show. Read More
Expert: Train Staff to Avoid ‘Land Mines’ in DocumentsDevice companies should train employees to take precautions when communicating through email and clean up incriminating paper trails that could come back to haunt them during a lawsuit or FDA inspection. Read More
Conducting Bulletproof CAPA Investigations — ADVANCED
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