Tag Archive: draft

Jan 09 2013

FDA’s Updated Guidance Outlines Timelines for Mandatory eCTD Submissions

On 03 January 2013, FDA released a draft revision to the Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications. The most significant update in this revision is information on FDA’s timeline for making eCTD submissions mandatory.  In the recent …

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Jan 09 2013

FDA's Updated Guidance Outlines Timelines for Mandatory eCTD Submissions

On 03 January 2013, FDA released a draft revision to the Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications. The most significant update in this revision is information on FDA’s timeline for making eCTD submissions mandatory.  In the recent …

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Apr 28 2010

New Disclosure Requirements for FDA Advisory Committees

Seldom, very seldom, does complete truth belong to any human disclosure. – Jane Austen On 21 April 2010, the FDA announced a newly revised Draft Guidance on Transparency and Advisory Committees.  If implemented, the draft guidance would increase transparency into the financial disclosures and conflicts of interest of Advisory Committee members. The FDA has 40 …

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