News

Regulatory Update | 25 March 2013

Australia and New Zealand Implement Harmonized OTC Regulatory System

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Australia’s Therapeutic Goods Administration (TGA) and New Zealand’s Medsafe have announced that a new over–the-counter (OTC) drug process for the evaluation of new and changed OTC medicines will be Read More...

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Latest News | 5 March 2013

Draft Guidance Increases FDA Flexibility During Interactive Reviews of Medical Device Submissions

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The US Food and Drug Administration (FDA) has released a new draft guidance for industry intended to clarify the types of communication used during the review of medical device product submissions Read More...

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Latest News | 29 January 2013

US Regulators Consider Formation of New Advisory Subcommittee to Study 'Data Liberation'

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The US Food and Drug Administration's (FDA) Science Board—an advisory board focused on the mission and competencies of the agency—will soon meet to start the process of reassessing a landmark 2007 Read More...

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Latest News | 28 January 2013

EMA to Conduct EU-Wide Review of Third-, Fourth-Generation Contraceptives

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French regulatory authorities, already reeling from two major scandals involving regulated healthcare products, are now facing yet a third involving an acne and contraceptive drug known as Diane-35.A Read More...

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Latest News | 3 January 2013

FDA Finalizes Three Critical Medical Device Guidance Documents

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The US Food and Drug Administration (FDA) has released three final guidance documents regarding the submission of nearly all medical device applications made to the agency.The guidance documents, 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 Regulatory Update | 6 November 2012

Australia's TGA Formulates New Steps for Drug Labeling and Packaging Review

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Australia’s Therapeutic Goods Administration (TGA) has reviewed the comments submitted on its Medicines Labeling and Packaging Review Consultation Paper, released in May 2012, and has identified six Read More...

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Latest News Regulatory Update | 5 October 2012

Brazil's Anvisa Addressing Drug Approval Priorities

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Brazil's national regulatory authority, Anvisa, announced on 4 October a number of steps it has implemented to address the priority public health needs of the country, part of a multi-year Read More...

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Latest News | 4 October 2012

New FDA Staff Policy Manual Defines 'Major Amendments' to Generic Drug Submissions

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The US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD) has released a new guideline for its internal review staff on how to handle amendments to generic drug applications.The Manual Read More...

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Latest News Regulatory Update | 1 October 2012

Health Canada Expands Use of Foreign Data

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Health Canada announced on 28 September the expansion of its pilot project on the use of drug review assessment information from foreign regulatory agencies, such as the European Medicines Agency, in Read More...

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