Tag Archives: labeling

New FDA Guidances for August 2013

New guidances out last month include several device related guidances including a beloved (at least by me) Q&A guidance on GLPs in premarket device submissions; a listing of FY 2014 medical device small business user fees; and new information on … Continue reading

Posted in FDA, Industry News | Tagged , , , , | Comments Off on New FDA Guidances for August 2013

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

Posted in FDA, Industry News | Tagged , , , , , | Comments Off on New FDA Guidances for April 2013

New FDA Guidances for March 2013

FDA released several interesting new guidances last month, including several regarding communications with the FDA. Types of Communication During the Review of Medical Device Submissions is in accordance with the MDUFA III goals and includes descriptions of acceptance review communications, substantive … Continue reading

Posted in FDA, Industry News | Tagged , , , , , | Comments Off on New FDA Guidances for March 2013

FDA’s New Guidances for February 2013

Several new guidance documents were released by FDA in February 2013, covering a wide range of subjects. S10 Photosafety Evaluation of Pharmaceuticals Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease Class II Special Controls Guideline: Temporary Mandibular … Continue reading

Posted in Clinical Trials, FDA, Regulatory Strategy | Tagged , , , , , | Comments Off on FDA’s New Guidances for February 2013

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

Posted in Clinical Trials, FDA, Industry News, Regulatory Strategy | Tagged , , , , , , , , | Comments Off on New FDA Guidances for January 2013