News

Latest News | 13 May 2013

Opening the Black Box: FDA Plans Study of DTC Advertising and Use of Composite Scores

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The US Food and Drug Administration (FDA) has announced that it plans to move forward with a proposed study on direct-to-consumer (DTC) advertising first announced in August 2012 regarding the use of Read More...

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Latest News | 28 January 2013

FDA Dropping Support for Study Data Submission Format

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The US Food and Drug Administration (FDA) will cease to support an older version of an electronic study data submission format in favor of a newer version of the same standard, it has announced.The Read More...

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Latest News | 15 January 2013

Study: Clinical Trial Site Activation, Enrollment Difficulties Slow Product Approvals

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A new study out from the Tufts Center for the Study of Drug Development (CSDD) indicates that it is difficult for companies to start up and enroll patients into clinical trials, with many trials Read More...

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Latest News | 19 December 2012

Industry Called Upon to Submit Proposed Improvements to Medical Device Review Process

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When it comes to the review of medical devices, how do you think the US Food and Drug Administration (FDA) is doing? While the question is usually left to be answered in the opinion pages of trade Read More...

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Latest News | 6 November 2012

Report: Inefficient Clinical Trials Cost Industry Billions Each Year

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Inefficient clinical trials are costing pharmaceutical development companies between $4 and $6 billion each year in unnecessary expenses, claims a new study just published by the Tufts Center for the Read More...

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Latest News | 10 October 2012

Proposed Study to Look at Effect of Advertising, Social Media on Prescribing Habits

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The US Food and Drug Administration (FDA) is preparing to conduct a survey of prescribing healthcare professionals regarding their assessment of promotional advertising generated by the pharmaceutical Read More...

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Latest News | 9 October 2012

Study: Priority Review-Approved Drugs Show Significantly More Problems Post-Approval

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More than 34% of drugs approved by Health Canada through its fast-track accelerated review framework ultimately require the addition of serious safety warnings or removal from the market, claims a new Read More...

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Latest News | 2 October 2012

Study: Clinical Trials Lag in Enrollment of Children

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Are the pharmaceutical industry and the National Institutes of Health doing enough to enroll children in clinical trials? No, claims a new study published in the journal Pediatrics and supported by Read More...

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Latest News | 24 September 2012

Biopharmaceutical Manufacturer Admits Faulty Data Reporting, Blames Contractor

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Biologics manufacturer Peregrine Pharmaceuticals' has informed its investors that its second-line lung cancer drug bavituximab, for which the company just released phase IIb data showing evidence of Read More...

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Latest News | 17 September 2012

Pharmacovigilance Concerns Lead Group to Call for Unique Names for Biosimilars

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A new survey released by the Alliance for Safe Biologic Medicines (ASBM), a group supported by branded biologics companies, says that biosimilar medicines should be required to use distinct names to Read More...

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