J&J Looks to Emerging Markets Amid Soft U.S. SalesJohnson & Johnson (J&J) is looking to emerging markets and diabetes care to propel future sales of devices and diagnostics, company executives said in a Jan. 24 earnings call. Read More
EC Seeks More Data on PIP Implants, Plans to Ramp up Device VigilanceDevicemakers across the EU should brace themselves for increased surveillance by competent authorities, including unannounced inspections, additional testing of products already on the market and heightened controls of notified bodies, the European Commission said following receipt of a “rapid scientific opinion” on the safety of faulty silicone breast implants. Read More
U.S., EU Devicemakers Promote Ethical Ties With DistributorsU.S. and European devicemakers should establish compliance programs integrating individual risk analyses with local laws to ensure ethical interactions with third-party distributors, an AdvaMed-Eucomed joint guidance states. Read More
FDA Offers Guidance on Humanitarian Use Device RequestsThe U.S. Food and Drug Administration (FDA) is asking for comments on new draft guidance on humanitarian use device (HUD) designations. Read More
First Test Approved for Brain Infection Linked to Multiple Sclerosis DrugThe first blood test that can measure multiple sclerosis (MS) patients’ risk for a rare but serious brain infection got FDA clearance Jan. 20. Quest Diagnostics’ Stratify JCV antibody test is the first blood test for qualitative detection of polyomavirus John Cunningham virus (JCV) antibodies. Read More
Industry Disappointed by TGA’s Weak Stand on Ethical CodesAustralian devicemakers are criticizing a Therapeutic Goods Administration (TGA) report on regulatory reform that fails to endorse a common industry conduct code. Read More
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J&J Looks to Emerging Markets Amid Soft U.S. SalesJohnson & Johnson (J&J) is looking to emerging markets and diabetes care to propel future sales of devices and diagnostics, company executives said in a Jan. 24 earnings call. Read More
EC Seeks More Data on PIP Implants, Plans to Ramp up Device VigilanceDevicemakers across the EU should brace themselves for increased surveillance by competent authorities, including unannounced inspections, additional testing of products already on the market and heightened controls of notified bodies, the European Commission said following receipt of a “rapid scientific opinion” on the safety of faulty silicone breast implants. Read More
U.S., EU Devicemakers Promote Ethical Ties With DistributorsU.S. and European devicemakers should establish compliance programs integrating individual risk analyses with local laws to ensure ethical interactions with third-party distributors, an AdvaMed-Eucomed joint guidance states. Read More
FDA Offers Guidance on Humanitarian Use Device RequestsThe U.S. Food and Drug Administration (FDA) is asking for comments on new draft guidance on humanitarian use device (HUD) designations. Read More
First Test Approved for Brain Infection Linked to Multiple Sclerosis DrugThe first blood test that can measure multiple sclerosis (MS) patients’ risk for a rare but serious brain infection got FDA clearance Jan. 20. Quest Diagnostics’ Stratify JCV antibody test is the first blood test for qualitative detection of polyomavirus John Cunningham virus (JCV) antibodies. Read More
Industry Disappointed by TGA’s Weak Stand on Ethical CodesAustralian devicemakers are criticizing a Therapeutic Goods Administration (TGA) report on regulatory reform that fails to endorse a common industry conduct code. 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
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
FDA Compliance Boot Camp 2012
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