Tag Archives: NDA

New FDA Guidances for February 2015

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in February 2015, are posted.  Two updates to the CDER Manual of Policies and Procedures (MAPP) are included.  … Continue reading

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New FDA Guidances for September 2013

September was a big month for CDRH Guidances.  Both the final Mobile Medical Applications Guidance and the much awaited Guidance on the Unique Device Identification Database were released.  More information about the Unique Device Identifier program can be found here. Specification of … 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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