In the newest posting of bioequivalence (BE) guidance documents (here), the Office of Generic Drugs has issued 35 new guidance documents and revised 22 previously issued guidances. We have previously posted about the impact of revised BE guidances and now there are 22 more that firms must review to see if any of the changes […]
FDA updated its Activities Report of the Generic Drugs Program Monthly Performance FY2018 with its January ANDA approvals and receipt numbers. The 25 full approvals reported for January is the lowest number since July 2014, when there were just 18 approvals. We have blogged about the potential for a very low January approval number here, […]
It looks like our guess was correct, and it also looks like OGD either liked our suggestion or, on its own initiative, decided to provide guidance to ANDA applicants concerning the best way to handle the submission of documentation on meeting the elemental impurities issue! The one pager (here) discusses the fact that submission of […]
The FDA published a Frequently Asked Question (FAQ) on Patents and Exclusivity on Friday (here). Turns out it is a very nice primer for those new to the generics or 505(b)(2) game or those that need a refresher in the ins-and-outs of two of the most contentious and confusing issues associated with the Drug Price […]
I must honestly say that there is not a lot that stands out in this update for the December ”Activities Report of the Generic Drug Program Monthly Performance” that we have not either already commented on, or where there appears to be a significant trend, albeit there are a couple of issues that we point […]
Here we are on January 29th and so far this month, there have been only 12 ANDAs approved and one tentative approval which have been posted on FDA daily approvals list. This month, January 23rd tops the number of approvals with 3 approvals listed. In previous months, we have seen as many as 11 approved […]
There is a big buzz about a new player in town but not a lot of information on how it plans to operate. Drug Store News reports “There will soon be a new generics manufacturer to contend with — one that comes with a built-in base of 450 hospitals. Four major health systems — Salt […]
FDA listed 106, either new or draft and/or revised draft guidances that it plans to issue in CY 2018. This is quite an ambitious agenda! This is a yearly exercise that FDA does and they have a tendency to come close to meeting their projections; be sure to review the entire list (here) to see […]
On January 11, 2018, we went out on a limb prognosticating that the very low numbers of ANDA approvals in January might be linked to a new USP requirement on documentation of elemental impurities that went into effect January 1st (see post here). Since that time, the number of approvals has jumped from 2 to […]
Too many medical device manufacturers are struggling because they don’t have policies and systems in place to handle the ever-growing amount of data they receive about their products once they’ve gone to market. As a result, important signals can go undetected or unaddressed, leading to compliance problems and devices that are of poor quality – […]
