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
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
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Lawmakers Lambaste Drugmakers for ‘Egregious’ PricesLawmakers outraged by what they call extraordinary drug price increases have asked the Government Accountability Office to see if the increases are justified and directed the Federal Trade Commission (FTC) to investigate a drug firm’s potential anti-competitive conduct for one product. Read More
CBER Guidance Addresses Trial Design for IGIV ProductsA statistical demonstration of a serious infection rate of less than 1 per person-year is adequate to provide substantial evidence of efficacy in clinical trials of investigational human immune globulin intravenous (IGIV) products, CBER says. Read More
FDA Launches Fellowship ProgramIn an effort to attract more scientific talent to the FDA, the agency is launching a two-year fellowship program designed to train scientists and engineers on the scientific foundations of its regulatory actions. Read More
DME Firm Owner Flees Country Following Fraud ConvictionThe owner of two south Florida durable medical equipment (DME) companies has fled the country after receiving a 130-month prison sentence for defrauding Medicare. Read More
St. Jude Gets FDA Approval of Wireless TransmitterThe FDA has approved St. Jude Medical's Merlin@home transmitter, a radio-frequency wireless technology that remotely monitors patients' implanted cardiac devices. Read More
SyntheMed Gets Canadian Approval for Adhesion TreatmentSyntheMed received Health Canada approval for the use of Repel-CV to reduce adhesions in pediatric patients who undergo open-heart surgery. Read More
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
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
Conducting Bulletproof CAPA Investigations — ADVANCED
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