Revised RTR Guidance – Merry Christmas!

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. 

Boxed Warning for Serious Mental Health Issues Removed from Chantix and Zyban Labeling

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. 

FDA Publishes List of First Bulk Drug Substances for 503A Compounding

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.

Approve Drugs for Safety Only – it’s Like “Back to the Future” – Not for Me

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.

Quality Agreements a “Must Have” for Use of CMO


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,

Happy Holidays – FDA Issues Highly Anticipated Revised Quality Metrics Guidance

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,

Another BE Guidance Revised – This Time, Sprinkle it With Fairy Dust!

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. 

This Turkey Wants to Wish You a Happy Thanksgiving

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,

Alert -Alert -Alert-Annual Program Fee Coming for GDUFA II – You Better be Ready!

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;