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Latest News | 22 May 2012

Report: Insufficient Regulatory Oversight Partially Responsible for Counterfeit Drugs

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An article published in The Lancet Infectious Diseases says nearly one-third of anti-malarial drugs in foreign countries are of insufficient quality, failing measures of chemical composition, adequate [Read More...]

Tags: drug Lancet Malaria Oversight Pharmaceutical Regulatory Regulatory Capacity Study
Latest News | 18 May 2012

‘Job-Killing’ Safety Regulations Not So Job-Killing, Says Study

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A new study published in the journal Science looking at safety regulations at worksites in California shows companies making an effort to strengthen safety measures for their employees cut down on [Read More...]

Tags: Profit regulations Regulatory Savings Study Workers Compensation
Latest News | 17 May 2012

UPDATED: Report: FDA Quicker Than EMA, Health Canada for Drug Approvals

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A study published in the New England Journal of Medicine (NEJM) claims the US Food and Drug Administration (FDA) is better at approving drugs than the European Medicines Agency (EMA) and Health [Read More...]

Tags: Approval drug EMA FDA Health Canada NEJM Pharmaceutical Review Study
Latest News | 11 May 2012

ICH Releases Update for E14 Guideline on Clinical Evaluation of Non-Antiarrhythmic Drugs

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The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has released an updated version of its Efficacy (E) 14 Guideline, [Read More...]

Tags: Clinical Trials E14 Guideline Harmonization Heart ICH Revised Revision Study
Latest News | 11 May 2012

Report: Outsourcing of Regulatory Services Rising Dramatically

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A new report out from the Tufts Center for the Study of Drug Development (TCSDD) has found the rate at which pharmaceutical companies are outsourcing their regulatory affairs services has risen [Read More...]

Tags: Outsourcing PDUFA Regulatory Study Tufts Center for the Study of Drug Development
Latest News | 10 May 2012

Indian Parliamentary Report Says Clinical Trials Not Being Conducted Properly

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A scathing report from the Parliament of India’s Standing Committee on Health and Family Welfare (SCHFW) indicates pharmaceutical companies in the country are increasingly moving their clinical trials [Read More...]

Tags: Approval Clinical Trial Heterogeneous Homogeneous India Parliament Regulatory report Small Study
Latest News | 9 May 2012

Study: Most Drugs Lacking Information on Adequate Pediatric Use

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A study conducted by researchers at the US Food and Drug Administration (FDA) finds fewer than half of all pharmaceutical products on the market do not contain any information for how the drug should [Read More...]

Tags: Children drug ePDR JAMA Kids PDR Pediatric Pharmaceutical report Study Testing
Latest News | 4 May 2012

EMA Adopts Guidance on Medical Products Containing Genetically Modified Cells

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The European Medicines Agency (EMA) announced 5 May it has adopted a scientific guideline on aspects relating to the development and testing of medicinal products containing genetically modified [Read More...]

Tags: Cells CHMP Clinical Trial Clinical Trials EMA Genetically Modified Cells GM GMC Manufacturing Non-Clinical Testing Pharmacovigilance Postmarketing Studies Quality Study
Latest News | 2 May 2012

Study: Many Clinical Trials Small, of Poor Quality

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Amidst an explosion in the number of clinical trials registered with US regulatory authorities, a new study analyzing clinical trials conducted in the US has found most of them to be relatively small [Read More...]

Tags: Analysis Clinical Trials ClinicalTrials.gov JAMA Quality Size Study
Latest News | 2 May 2012

FDA Disputes Study Findings, Goes After Some Clinical Trial Sponsors

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Months after the British Medical Journal (BMJ) reported that the US Food and Drug Administration’s (FDA) oversight of its clinical trials database was suffering from serious lapses in clinical trial [Read More...]

Tags: BMJ Clinical Trials ethics FDA NIH Published Studies Study Transparency Warning
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