Survey Gives Tips for Devicemakers to Reduce Battery ProblemsHealthcare providers experience the most frequent battery problems with large-volume infusion pumps and would like manufacturers to add green, yellow and red LED lights that change color when the battery status changes. Read More
Strong Compliance Program Hinges on CEO CommitmentStrong buy-in at the top is essential to developing and maintaining a successful compliance program, experts told attendees at the Medical Device Manufacturers Association meeting last month. Read More
$20M Goldman Sachs Investment Highlights Indian Medtech GrowthGoldman Sachs last week announced plans to invest about $20 million in Indian devicemaker BPL Medical Technologies, marking one of the largest medtech investments made to date in an emerging market. Read More
U.S. FDA Losing Global Ops Chief AutorDeborah Autor, U.S. Food and Drug Administration deputy commissioner for global regulatory operations and policy, is leaving to join the regulatory policy team at generic drugmaker Mylan. Read More
Report Points to Steep Four-Year Rise in Device Warning LettersThe FDA has stepped up its inspections of devicemakers over the last four years, resulting in a steep increase in warning letters, a new report finds. Read More
Anvisa Harmonizes Device, IVD GMPsBrazil is streamlining its good manufacturing practice requirements, replacing RDC 59/2000 for medical devices and Ordinance 686/1998 for in vitro diagnostics with a single regulation, RDC 16/2013. Read More
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Survey Gives Tips for Devicemakers to Reduce Battery ProblemsHealthcare providers experience the most frequent battery problems with large-volume infusion pumps and would like manufacturers to add green, yellow and red LED lights that change color when the battery status changes. Read More
Strong Compliance Program Hinges on CEO CommitmentStrong buy-in at the top is essential to developing and maintaining a successful compliance program, experts told attendees at the Medical Device Manufacturers Association meeting last month. Read More
$20M Goldman Sachs Investment Highlights Indian Medtech GrowthGoldman Sachs last week announced plans to invest about $20 million in Indian devicemaker BPL Medical Technologies, marking one of the largest medtech investments made to date in an emerging market. Read More
U.S. FDA Losing Global Ops Chief AutorDeborah Autor, U.S. Food and Drug Administration deputy commissioner for global regulatory operations and policy, is leaving to join the regulatory policy team at generic drugmaker Mylan. Read More
Report Points to Steep Four-Year Rise in Device Warning LettersThe FDA has stepped up its inspections of devicemakers over the last four years, resulting in a steep increase in warning letters, a new report finds. Read More
Anvisa Harmonizes Device, IVD GMPsBrazil is streamlining its good manufacturing practice requirements, replacing RDC 59/2000 for medical devices and Ordinance 686/1998 for in vitro diagnostics with a single regulation, RDC 16/2013. 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
Tenth Annual Medical Device Quality Congress
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