Tag Archives: ANDA

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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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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New Guidances from FDA for October 2012

FDA released four notable new guidances in October 2012, with a focus on guidances related to medical devices: Guidance: E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs — Questions and Answers (R1) Guidance: FDA and … Continue reading

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Meningitis Tragedy Leads to Calls for Increased FDA Oversight

On 25 September 2012, three lots of steroid injections intended to treat pain were recalled by the pharmaceutical compounding company New England Compounding Center (NECC) in Framingham, MA, because of fungal contamination.  By Thursday, 11 October 2012, 12 people had … Continue reading

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New FDA Guidances from September 2012

There were only a few guidances released by FDA in September 2012: Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products Final Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion Complicated … Continue reading

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