Ever wonder how many Rx-OTC switches FDA has made over the years? Well, now we have that data from 2001 through 2016 and that number is reported at 38 by the FDA – albeit, there are a few in that total that are not true Rx-to-OTC switches (we will explain that later). Over the last […]
The recently issued Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance document (here) states that the FDA considers that the owner’s (those who engage the services of the contract facilities) Quality Unit responsibility includes approving or rejecting the contract facility’s product or service (be it for testing, processing, packing or holding). In addition, as […]
On Thanksgiving Eve, FDA issued the revised Quality Metrics Guidance. Is the revised document something for industry to be thankful for? Let’s break it down: Allowance for a phased-in, voluntary approach – This is something that many industry groups have been asking for, since the burden, as well as the complexity of collecting metrics from […]
On Monday, the Office of Generic Drugs (OGD) updated its report on the activity of the Generic Drug Program to include additional data. As this is the report for the first month of the new fiscal year (2017), any comparative data needs to come from previous fiscal years. The October report adds Refuse-to-Receive (RTR) actions, […]
FDA has revised its bioequivalence recommendation for cyclobenzaprine hydrochloride extended-release capsules. This revision was based on a petition submitted by the current NDA holder and marketer of the product (here). In that petition, the NDA holder requested that FDA require any ANDA applicant to perform an additional bioequivalence study beside the fasting and fed in-vivo […]
Whether you are into tofurkey, real turkey, ham or whatever floats your boat, all of us at Lachman Consultants want to take a moment to wish you and yours a happy Thanksgiving. At this time of year, we all need to take stock (no pun intended) of our family and friends and realize that, while […]
In the GDUFA II negotiations, there have been some significant changes in the fee structure. For instance, no facility will pay an establishment fee until it is named in an approved application; CMOs will only pay one-third of the establishment fee when named in an approved application; the prior approval supplement fee has been eliminated; […]
We have taken a bit of a break from describing some of the key features of the 341-page Final Rule that issued in February 2016, due to all of the other news that has gotten in the way. This post continues to provide salient sections of the Final Rule and describes their impact. Interestingly, as previously described, […]
The first month of FY 2017 was about the same as most months in FY 2016. OGD fully approved 54 ANDAs and tentatively approved 16 ANDAs for a total of 70 approval actions to open the 5th year of GDUFA. Complete Response Letters stood at 151 for the month – again on par with what […]
Yesterday, we posted an update on the first-time generic approvals from OGD for FY 2016. At the end of the day (hours after our blog publication), the FDA updated their chart. The number in the chart changed from 70 to 72 but then I noticed my error-the report was for the CALENDAR year not the […]
