Tag Archives: BLA

New FDA Guidances for June 2013

FDA was busy last month and released 14 Guidances to prove it, including the long awaited Guidance discussing the Breakthrough Therapy designation that was enacted by FDASIA.  Look for a review of “Expedited Programs for Serious Conditions––Drugs and Biologics” coming … Continue reading

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New FDA Guidances for April 2013

There were many new Guidances out in April.  Notably, changes in postmarketing periodic safety reporting are discussed in this guidance.  See CATO’s take on some of the changes in postmarket reporting here. SUPAC: Manufacturing Equipment Addendum  Glass Syringes for Delivering … Continue reading

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New FDA Guidances for January 2013

FDA has already released a handful of new guidances to start off the year 2013.  They include: Guidance for Industry and FDA Staff: Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA Humanitarian Use … Continue reading

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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 … Continue reading

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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 … Continue reading

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