I can’t believe another year has slipped away already. Seems like yesterday I was writing the holiday blog for 2015 and here we are again. This year brought us the renegotiations of all of the UFAs, the largest number of Generic Drug approval since the new counting system went into effect (for those of you who don’t know what I am talking about – you are too young,
We are pleased to announce that Michael Keech will join Lachman Consultants as Head of Business Strategy, effective January 3, 2017.
Mr. Keech comes to Lachman Consultants as a seasoned Quality, Compliance and Manufacturing professional who has worked in the Life Sciences field for over 25 years. Mr. Keech has helped global corporations transform into world-class organizations by providing strategic and tactical guidance on regulatory requirements and compliant solutions involving the clinical and commercial manufacture/control for pharmaceutical,
We are pleased to announce that Linda Evans O’Connor, M.B.A. has been promoted to Head of Business Processes and Regulatory at Lachman Consultant Services, Inc. Ms. Evans O’Connor will continue in her recognized leadership role as part of the Compliance Practice and will oversee the administrative activities of the Regulatory Department as well as support the on-going development of the Lachman brand and marketing strategy.
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.
On September 19, 2016, we posted a blog (here) announcing the FDA-sponsored competition to create an app that will connect victims of overdose with carriers of naloxone. Well, now we know the winner, and we also know that the competition attracted significant attention, as 150 teams registered for the competition and FDA received 45 submissions,
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.
We are pleased to announce that Daniel Barreto will join Lachman Consultants as Vice President, Compliance Practice, effective December 12, 2016.
Mr. Barreto comes to Lachman Consultants with nearly four decades of extensive international experience in the pharmaceutical industry developing and implementing quality strategies and programs to support a continuous state of compliance and consistent state of inspection readiness.
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,