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Latest News | 29 January 2013

FDA Touts Accomplishments, Impact of Anti-AIDS Program

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US regulators are touting the success of a regulatory review program that they say has been responsible for approving dozens of drug products intended for use in developing countries—and in particular Read More...

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Latest News | 28 November 2012

IOM Calls for Regulatory Harmonization

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The Institute of Medicine (IOM) wants the practice of regulatory affairs to be a little bit easier, particularly for low-resource countries and companies conducting international clinical trials.In an Read More...

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Latest News | 25 October 2012

Restricted Travel, Conference Budgets Could Harm Regulators, Say Critics

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Government oversight bodies wary of fraudulent and unscrupulous expenditures made during agency-sponsored conferences have recently begun to crack down on how much money the agencies can spend, Read More...

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Latest News | 25 October 2012

Asian Regulatory Harmonization Plan Calls for Investments in Regulatory Capacity

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The Asian Harmonization Working Party (AHWP), a standards harmonization group focused on medical devices, has released a strategic framework and two proposed standards for public comment.The group, Read More...

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Latest News | 24 October 2012

Regulators: Need to Pay More Attention to Regulatory Capacity of Developing World

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Little attention has been paid to the regulatory systems in low- and middle-income countries across the world, causing a huge and negative impact on global public health, argue three employees of the Read More...

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Latest News | 2 October 2012

In Wide-Ranging Interview, Hamburg Looks Back on First Four Years as Commissioner

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US regulators are increasingly reaching out to partner with their foreign counterparts, transitioning from a domestic agency to one with a global focus, said US Food and Drug Administration (FDA) Read More...

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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...

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Latest News | 15 May 2012

New FDA Program Aims to Develop New Approaches to Clinical Trials, Pharmacovigilance

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A new program announced by the US Food and Drug Administration aims to strengthen global regulatory capacity by working with the World Health Organization (WHO) to support new, innovative approaches Read More...

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Latest News | 3 May 2012

CBER Wants Better Vaccine Safety, Identify Adverse Events

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The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) is announcing its intent to launch a program to ensure the safety of vaccine products manufactured Read More...

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Latest News | 1 May 2012

Report: FDA Increasingly Playing Key Role in Global Health

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A report issued by the Global Health Technologies Coalition (GHTC), a coalition of 40 non-profit groups including the Bill & Melinda Gates Foundation, argues that the US Food and Drug Administration’s Read More...

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