Tag Archive: Federal Register

Jan 30

Combination Products: What’s New?

A monoclonal antibody combined with a therapeutic drug. An EpiPen®. A drug packaged with its delivery device. All of these are examples of combination products. A combination product, according to the FDA, is “a product composed of any combination of a drug and a device; a biological product and a device; a drug and a …

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Jan 09

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

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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Oct 10

Clinical Trial Reporting

On 26 September 2012, a notice was published in the Federal Register that the Department of Health and Human Services was transferring responsibility to the FDA for ensuring that clinical trial data is appropriately submitted to Clinical Trial Registry and Results Data Bank (which is also known as ClinicalTrials.gov) and that the data is complete …

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Apr 08

FDA Proposes New Direct-to-Consumer (DTC) Advertising Rules

Good advertising does not just circulate information.  It penetrates the public mind with desires and belief. – Leo Burnett The FDA recently published a proposed rule for how risk information should be presented in Direct-to-Consumer (DTC) advertising.  Per FDAAA 2007, the FDA was mandated to ensure that the description of side effects and contraindications (the …

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