 CBER Five-Year Plan Aims to Speed Adverse Event Analysis, Cut Down on Phase III FailuresCBER hopes to speed studies of biologic adverse events within the next five years by using the FDA’s Mini-Sentinel postmarket surveillance pilot in partnership with other government agencies and private organizations. Read More
No Sunshine in 2012: Physician Reporting Rules Pushed Back AgainThe Centers for Medicare & Medicaid Services (CMS) is sparing devicemakers and group purchasing organizations from reporting payments made to doctors and hospitals in 2012, as the agency continues to lag behind deadlines for issuing final Sunshine Act regulations. Read More
EMA Outlines Plan to Ensure Quality of Foreign Clinical TrialsThe European Medicines Agency must increase inspections of foreign trials and work with regulators and ethics bodies in other countries to ensure there is a robust framework for the oversight and conduct of clinical trials, a new EMA report concludes. Read More
REMS Evaluations Not Perfect, FDA Questions Assessment MethodsThe FDA is questioning surveys and other assessment methods drugmakers are using to evaluate whether risk evaluation and mitigation strategies (REMS) work. Read More
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
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No Sunshine in 2012: Physician Reporting Rules Pushed Back AgainThe Centers for Medicare & Medicaid Services (CMS) is sparing devicemakers and group purchasing organizations from reporting payments made to doctors and hospitals in 2012, as the agency continues to lag behind deadlines for issuing final Sunshine Act regulations. Read More
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
EMA Outlines Plan to Ensure Quality of Foreign Clinical TrialsThe European Medicines Agency must increase inspections of foreign trials and work with regulators and ethics bodies in other countries to ensure there is a robust framework for the oversight and conduct of clinical trials, a new EMA report concludes. Read More
REMS Evaluations Not Perfect, FDA Questions Assessment MethodsThe FDA is questioning surveys and other assessment methods drugmakers are using to evaluate whether risk evaluation and mitigation strategies (REMS) work. Read More
Expert: Don’t Expect Guidance on Biosimilar Interchangeability Anytime SoonDrugmakers looking to branch into biosimilars shouldn’t raise their hopes for quick FDA guidance on achieving interchangeability status. Read More
MHRA’s New Falsified Medicines Strategy Takes Aim at InternetThe UK’s Medicines and Healthcare products Regulatory Agency (MHRA) unveiled a new anti-counterfeiting strategy that builds off a 2007 strategy with increased international collaborations to fight the expanding risk of fake drugs online. Read More
Too Many Small Studies Among Flaws Seen in U.S. Trials EnterpriseClinical trial stakeholders must look for opportunities to join forces on larger, more meaningful studies to boost trial efficiency, a Duke University researcher says. Read More
Conducting Bulletproof CAPA Investigations — ADVANCED
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