• Report Finds Huge Variations in CDER Performance, but Few Explanations as to Why

    New research published by the Manhattan Institute for Policy Research (MIPR), a right-leaning think tank which focuses in part on pharmaceutical regulation policy, indicates that there are wide gaps in performance among the US Food and Drug Administration's (FDA) review divisions, resulting in a "productivity gap" that has left some patients without ready access to new therapies. Background MIPR's research report, An FDA Report Card: Wide Performance Found Among Agenc...
  • When is a Live Case Presentation Promotional? FDA Draft Guidance Clarifies

    A new draft guidance document published by the US Food and Drug Administration (FDA) is aimed at clarifying which information should be included in an investigational device exemption (IDE) application if the sponsor intends or anticipates including a "live case presentation" during the course of the clinical trial. Background Many high-risk (Class III) "significant risk" medical devices are subject to the premarket application (PMA) process, which requires sponsors to ...
  • Study Finds Widespread Problems in Reporting of Clinical Trial Results

    According to a new study published in the Journal of the American Medical Association (JAMA) , the results of clinical trials reported to the public are frequently inaccurate, raising questions about the accuracy of current and future trial transparency efforts. The study, Reporting of Results in ClinicalTrials.gov and High-Impact Journals , looked at 96 different research trial results published in prestigious medical journals (impact factor greater than or equal to 1...
  • FDA Research Finds Women Under-Represented in Post-Approval Device Trials

    New research by regulators with the Center for Devices and Radiological Health (CDRH) has found that gender-specific data is not always assessed in postmarketing studies on the safety and efficacy of a device, potentially putting women at risk. Emphasis on Women CDRH, the US Food and Drug Administration's (FDA) medical device regulatory division, has been placing an increasing emphasis on the needs of women in recent years. In December 2011 it released a draft guidanc...
  • FDA Lays Groundwork for Study of Behaviors of Consumers and Healthcare Professionals

    A new contract announcement just issued by the US Food and Drug Administration (FDA) says it is looking for a contract partner with which to conduct behavioral research on how consumers and healthcare professionals react to promotional materials and labeling. The notice, known as a Request for Information (RFA), is intended to identify companies capable of conducting market research for FDA in the area of behavioral research. "The Agency is interested in organizations w...
  • FDA Signs Off on Par Pharma's Bioequivalence Study on Generic Wellbutrin Even as Questions Remain

    The US Food and Drug Administration (FDA) has approved a supplemental Abbreviated New Drug Application (sNDA) sponsored by Par Pharmaceuticals for a 300 mg, extended-release version of the popular antidepressant Wellbutrin XL (bupropion). The approval appears to be the first since the agency formally withdrew a nearly identical drug from the market several months ago after the product was found to not be bioequivalent to the reference listed drug (RLD). Background In Se...
  • A Generic Conundrum: How do you Study a Drug that has Been Withdrawn from the Market?

    In March 2013, the US Food and Drug Administration (FDA) formally withdrew approval for Impax Laboratory's buproprion hydrochloride extended release 300 mg (Budeprion XL 300 mg), saying the drug had been found to not be bioequivalent to its reference listed drug, Wellbutrin XL 300 mg. Soon thereafter, the agency announced it was looking for a company to further study the issue of why Impax's drug wasn't bioequivalent when several other generic products did not exhibit sim...
  • New FDA Study to Look at Causes of Failure in Hip Implants

    One of the largest medical device scandals in the last decade has involved metal-on-metal hip implants, so-named because of the metal (usually chromium) attachment that attaches a leg to a metal socket. In the wake of their failures, the US Food and Drug Administration (FDA) moved to examine its regulatory processes, eventually deciding to require premarket approval (PMA) applications for all such implants. But now evidence has emerged that the agency still has further q...
  • FDA Plans Multi-Year Investigation Into Rare Side-Effect of Heparin

    The US Food and Drug Administration (FDA) has announced that it will give researchers a quarter of a million dollars to help identify the source of a major safety risk now affecting heparin products. Heparin, a mixture of non-standard-length polysaccharides, acts as an anticoagulant under normal circumstances. However, a notable side effect known as heparin-induced thrombocytopenia (HIT) results in a decrease of platelets in the blood resulting in the release of abnormal...
  • Opening the Black Box: FDA Plans Study of DTC Advertising and Use of Composite Scores

    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 composite scores in advertising and whether consumers have sufficient understanding to allow for their use. Background Composite scores are essentially a collection of clinical endpoints combined into a single overall score. For example, an allergy drug might use a comp...
  • Does Corrective DTC Advertising Work as Intended? FDA Study Plans to Find Out

    For the second time this week, FDA has announced that the Office of Management and Budget (OMB), the government's regulatory oversight body and clearinghouse, has signed off on a study it intends to conduct regarding correct advertising aimed directly at consumers, otherwise known as corrective DTC advertising. Background The study was first announced in draft form in February 2012, when FDA issued a notice in the Federal Register saying it intended to research "how c...
  • Study: Clinical Trial Site Activation, Enrollment Difficulties Slow Product Approvals

    • 15 January 2013
    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 taking almost twice as long as initially expected and more than one in 10 trials never enrolling a single patient. The study's findings could have implications for regulatory professionals, who often oversee all or parts of the clinical trials process and are often responsible fo...