Cook Says FDA is Delivering at OGD Update During GPhA meeting

Dr. Kathleen “Cook” Uhl, Director of the Office of Generic Drugs provided an update on the progress of OGD in the implementation of GDUFA I.  Despite the “tension” and uncertainty noted by the panel that preceded her (see yesterday’s post), Cook delivered a strong message that OGD has meet all of its GDUFA goals to date and has gone above and beyond the goals outlined in the GDUFA goals letter.

Gottlieb Panel Feels the Tension with OGD

Scott Gottlieb, MD hosted a three-person panel on the closing day of the GPhA Annual Meeting just before Dr. “Cook” Uhl presented the Office of Generic Drug (OGD) update. Scott fired questions at Kate Beardsley (Beardsley Law PLLC), Sheldon Bradshaw (former Chief Counsel FDA and now a partner with Hunton and Williams LLP), and Frances Zipp, (President and CEO, Lachman Consultants).

GDUFA II Negotiations and FDA Trends

We all know that the GDUFA II negotiations are in full swing.  Among topics being discussed are fee issues associated with small businesses and especially the subject of establishment fees and whether they should be collected only after ANDA approval.  This is also on the radar of Congress and will likely get some significant attention in the negotiation discussions.

FDA Finalizes Guidance on Low Molecular Weight Heparin Characterization and Immunogenicity Considerations

Today, the FDA published its final updated Guidance entitled, Immunogenicity – Related Considerations for Low Molecular Weight Heparin (LMWH) (here).  The document provides advice on the proper characterization of active ingredient sameness (for ANDAs), as well as considerations for immunogenicity testing for such products.  The document provides guidance for NDA holders (for new products or changes to existing products) and for ANDA applicants. 

More on the New Guidance Documents FDA Plans to Issue in 2016

On January 25, 2016, this blog posted an article about some of the Guidance documents that FDA was planning to issue as new and or revised this coming year (here).  In that blog post, it was noted that an update to that post would be coming-well here it is!

Some of the other notable documents we can all be looking for this year (with a little bit of editorializing) include,