First issued in draft in 2004 and then revised as a draft in 2015, Revision 1 of the Guidance document “Botanical Drug Development” issues in final form. The Guidance reflects current Agency thinking on the drug development process for new drugs (NDAs), investigational new drug applications (INDs) to support NDAs, and a discussion of the […]
OGD posted additional statistics relative to metrics that it routinely tracks by month. Included in these numbers are data on Refuse-to-Receive (RTR) actions, supplements received, controlled correspondence, etc. All of FY 2016 monthly RTR actions were in the double digits except for September, which saw only 9 RTR actions. Well, 2017 seems to be starting […]
The Office of Generic Drugs (OGD) has been busy in the bioequivalence arena as evidenced by its issuing of 31 new recommendations and revising 17 previously issued recommendations. The list of new and revised recommendations can be found here. As always, there are some specific recommendations that are of note while others are standard bioequivalence […]
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 […]
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 […]
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 […]
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 […]
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 […]
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. Specifically, the Agency […]
