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 […]
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 […]
Well, we did not have to wait long after the blog post on upcoming Guidance documents for the DMF Completeness Assessment (CA) Guidance to issue (here). The document begins with a concise discussion of the GDUFA requirements for DMFs submitted to support approval of generic applications, including the requirements for fees, what triggers a […]
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 […]
The number of approvals reported yesterday was revised upwards by 1 to 43, according to the Office of Generic Drugs (OGD).
The Washington DC. / Maryland “snowmageddon” event causing the closure of the Federal Government for a few days may have resulted in a dip in ANDA approvals in the first month of calendar year 2016. The Office of Generic Drugs (OGD) fully approved 42 ANDAs and tentatively approved 17 ANDAs in January. Four months […]
FDA issued a revised bioequivalence recommendation for Lamotrigine ER Tablets calling on the firms to perform fasting and fed bioequivalence studies on the 200 mg tablet and a fasting study on the 50 mg. Neither of these products are the highest or lowest strength in the product strength range of 25 mg to 300 mg […]
When most people hear of Amazon.com, they think of one of the largest online marketplaces for consumer products. What people may not realize is that Amazon is also one of the largest providers for computer power for cloud computing through their subsidiary Amazon Web Services (AWS). Running applications in the cloud is a relatively new […]
While 26-30 Inches of snow fell in the Washington DC corridor, the brunt of the storm has hit the FDA with offices being closed today while the dig out continues. For those of you who had GDUFA, PDUFA goal dates, or TADs scheduled for today, you may have to wait a day or two more […]
On Friday January 22, CDER issued its yearly document outlining what Guidance documents it hopes to issue in 2016. This yearly wish list is always a highlight of the beginning of every calendar year. The document identifies either new guidance documents FDA hopes to release, as well as those it plans to revise. This year […]
