Industry: IRS Needs to Better Define ‘Taxable Use’ in Excise Tax RuleInternal Revenue Service guidelines on the 2.3 percent medical device tax should make clear that manufacturers won’t have to pay taxes on products from which they derived no direct benefit, such as demonstration products and replacement parts provided free of charge, AdvaMed said in comments on a proposed rule on the tax. Read More
Improved Data Sharing With International Partners at Core of U.S. FDA Global PlansOver the next several years, the U.S. Food and Drug Administration (FDA) will engage more with its international counterparts through systems that will allow it to share real-time information and resources in a more comprehensive way than is currently possible. Read More
MDUFA Moves to House Floor, Decision Summaries for Some 510(k)s LikelyAn omnibus FDA user fee bill passed last week by the House Energy and Commerce Committee includes a variety of measures aimed at reforming the medical device regulatory process, including a provision requiring the FDA to withdraw its controversial guidance on when manufacturers should submit 510(k)s on modified devices. Read More
Developed, Developing Nations Should Work in Tandem to Ensure Safe ImportsThe U.S. Food and Drug Administration (FDA) and other agencies must provide expertise, training and tools to developing nations to improve their device and drug monitoring practices and prevent dangerous healthcare products from entering the U.S., according to an April 4 Institute of Medicine (IOM) report. Read More
Stricter Investigator Disqualification Standards Go Into Effect This MonthAn FDA final rule with stronger restrictions on the work of disqualified trial investigators takes effect May 30 and nearly mirrors an April 2011 proposed version that received little stakeholder feedback. Read More
Bulgaria to Create Electronic Register to Increase Medtech TransparencyBulgaria is creating an electronic register of medical devices to promote transparency and increase its control over device procurement, according to PMR, a British-American company providing information to international businesses interested in Central and Eastern Europe. Read More
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Industry: IRS Needs to Better Define ‘Taxable Use’ in Excise Tax RuleInternal Revenue Service guidelines on the 2.3 percent medical device tax should make clear that manufacturers won’t have to pay taxes on products from which they derived no direct benefit, such as demonstration products and replacement parts provided free of charge, AdvaMed said in comments on a proposed rule on the tax. Read More
Improved Data Sharing With International Partners at Core of U.S. FDA Global PlansOver the next several years, the U.S. Food and Drug Administration (FDA) will engage more with its international counterparts through systems that will allow it to share real-time information and resources in a more comprehensive way than is currently possible. Read More
MDUFA Moves to House Floor, Decision Summaries for Some 510(k)s LikelyAn omnibus FDA user fee bill passed last week by the House Energy and Commerce Committee includes a variety of measures aimed at reforming the medical device regulatory process, including a provision requiring the FDA to withdraw its controversial guidance on when manufacturers should submit 510(k)s on modified devices. Read More
Developed, Developing Nations Should Work in Tandem to Ensure Safe ImportsThe U.S. Food and Drug Administration (FDA) and other agencies must provide expertise, training and tools to developing nations to improve their device and drug monitoring practices and prevent dangerous healthcare products from entering the U.S., according to an April 4 Institute of Medicine (IOM) report. Read More
Stricter Investigator Disqualification Standards Go Into Effect This MonthAn FDA final rule with stronger restrictions on the work of disqualified trial investigators takes effect May 30 and nearly mirrors an April 2011 proposed version that received little stakeholder feedback. Read More
Bulgaria to Create Electronic Register to Increase Medtech TransparencyBulgaria is creating an electronic register of medical devices to promote transparency and increase its control over device procurement, according to PMR, a British-American company providing information to international businesses interested in Central and Eastern Europe. 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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