Today, FDA released a second revision to the ANDA Submissions – Refuse-to-Receive Standards, here, a holiday present to all. OGD noted that the RTR rate hovered between 10-14% over the last few years and a total of 379 ANDAs (not related to failure to pay required GDUFA fees) have been RTR-ed ANDAs during FY 2013 through FY 2015.
Back in April 2016, we posted a blog regarding the potential for the FDA to remove the Black Box warning on two products indicated to help patients stop smoking based on a large clinical study that the FDA required. At that time when the studies were submitted, the Agency indicated it would review the results and make a final determination.
The FDA issued a Proposed Rule (here) that announced the first additional 6 bulk drug substances for inclusion on the listing of bulk drug substances acceptable for pharmacy compounding, although they are neither the subject of an applicable United States Pharmacopoeia (USP), nor National Formulary (NF) monograph, nor components of FDA-approved drugs.
The numbers of ANDAs that were approved, received as well as a few other of the usual early statistics for November were released yesterday and the numbers are a bit troubling. While FDA did approve a few more ANDAs in November than it did in October (which was the start of FY 2017), 59 vs 54,
I usually don’t comment on political issues, but I am happy to take on this argument with zeal. While listening to the concept of FDA going back to the 1938 Federal Food, Drug and Cosmetic Act’s “safety only” approval provision over the last few weeks, I have sat quietly until my blood boiled over. I read a very responsible piece by Ed Silverman this morning (here) and it moved me off my couch and to my computer because I just had to say something.
On November 21, 2016 we issued an important alert (here) relative to the FDA activities regarding the proposed GDUFA II Program Fees and the responsibility of industry to review the list and provide feedback to FDA relative to its accuracy and whether there was an affiliate relationship among entities listed.
In a November 28, 2016 FDA response denying two Citizen Petitions (here) asking that the Agency determine that the older discontinued formulation of Protonix IV was not withdrawn for safety of efficacy reasons, the FDA said it was and provided a 7-page explanation of its reasons.
They explained that when Protonix IV was first approved,
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 5 years,
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,
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 large,
The Government Accountability Office (GAO) issued a 70-page report (here) November 2016 on Drug Compounding, which will keep the pressure up for enforcement of the 2013 Drug Quality and Security Act (DQSA). The lengthy GAO Report is enlightening in that it examines: settings in which drugs are compounded; state laws and enforcement;
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 studies that were originally recommended.
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 we all have difficult jobs,
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;