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Regulatory Intelligence | 3 January 2012

Senators Call for Task Force on Adverse Drug Reactions

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A study in the New England Journal of Medicine (NEJM) has prompted two Senators to call for a joint task force to be created.Sens. Olympia Snowe (R-ME) and Michael Bennet (D-CO) have requested that [Read More...]

Tags: ADE Adverse Drug Events Congress DHHS Task Force
Regulatory Intelligence | 3 January 2012

ULTRA Bill Introduced in the House; Legislation Seeks to Permit Broader Use of Scientific Data to Support Surrogate Endpoints for “Ultra Orphan” Drug Approvals

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Two congressmen have introduced legislation that would amend the Food, Drug and Cosmetic Act to provide an easier, accelerated approval pathway for drugs for “Ultra Orphan” diseases, which affect [Read More...]

Tags: Accelerated Pathway Cliff Sterns Congress Ed Towns FDA Orphan Diseases ULTRA Ultra-Rare Diseases
Regulatory Intelligence | 26 December 2011

A Push to Tie New Drugs to Testing

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Pharmaceutical companies are learning that it is often not enough simply to bring a drug to market.  Regulators and insurers are also prodding the companies to develop tests to pinpoint which patients [Read More...]

Tags: Companion Diagnostics Diagnostics Drugs FDA
Regulatory Intelligence | 22 December 2011

President’s Bioethics Commission Releases Report on Human Subjects Protection

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The Presidential Commission for the Study of Bioethical Issues on 15 December issued its report concerning federally sponsored research involving human volunteers, concluding that current rules and [Read More...]

Tags: Bioethics Commission ethics Human Subjects Protection Obama Research Safeguards
Regulatory Intelligence | 21 December 2011

Korea to Bring Certification for Clinical Trial Experts

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Korea National Enterprise for Clinical Trials (KoNECT) held a public hearing on 3 November, 2011 regarding the creation of a certificate system for clinical trials experts.  Intended for PI, CRC and [Read More...]

Tags: Clinical Clinical Trial KoNECT Korea trial
Regulatory Intelligence | 21 December 2011

Joint FDA-EMA Inspection Program to Launch in January 2012

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The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will begin sharing facility inspection data in their respective territories in January to make better use of resources [Read More...]

Tags: database EMA FDA Inspection Sharing
Regulatory Intelligence | 21 December 2011

Rule would Require Device, Drug Firms to Report Payments to Providers

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The Centers for Medicare & Medicaid Services (CMS) issued a Sunshine Law proposal requiring health care manufacturers to report all gifts and payments to doctors and teaching hospitals to a public [Read More...]

Tags: CMS GPOs Sunshine
Regulatory Intelligence | 21 December 2011

Austen BioInnovation Institute, FDA to Partner on Medical Device Regulation

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The Austen BioInnovation Institute in Akron (ABIA) is collaborating with the US Food and Drug Administration to share its expertise in the use of biomaterials and polymers in medical devices. [Read More...]

Tags: Biomaterials FDA medical devices Polymers Sharing
Regulatory Intelligence | 21 December 2011

FDA Guidance: How to Win Humanitarian Use Device Designation

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The US Food and Drug Administration (FDA) released new draft guidance detailing the submission process for products seeking humanitarian use device designation for the US market. The document aims to [Read More...]

Tags: FDA HUD Humanitarian Use Device process submission
Regulatory Intelligence | 21 December 2011

FDA Issues Interim Rule on Drug Production Discontinuance

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The US Food and Drug Administration (FDA) issued an interim final rule last week that clarifies what a 'discontinuance' of production of a drug is and what 'sole manufacturer' means when it comes to a [Read More...]

Tags: discontinuance discontinue FDA interim final rule manufacturer production sole manufacturer
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