Can We Call It the Affirmation of a “Beautiful Friendship”?

FDA has announced the availability of another draft guidance for industry entitled, Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process.  The draft guidance is part of FDA’s continued support of the Drug Competition Action Plan and to encourage the generic industry to take advantage of the USP’s Pending Monograph Process that was initiated in 2015.

New FDA Guidance Released on Live Case Presentations for IDE Clinical Trials

We are living in a world that is constantly changing and using forms of media such as videos and live recordings as forms of communication, notification, training and archiving of special events.  In this age, we are constantly bombarded with Tweets, G-Chats and Facebook posts that have videos attached.  We can stream tv shows, live news reporting and sports events in real time.  

Real World Data and Evidence Coming to an Application Near You?

The FDA released a draft guidance today titled Submitting Documents Using Real-World Data and Real‑World Evidence to FDA for Drugs and Biologics (here) that describes how the Agency will receive Real World Data (RWD) and Real World Evidence (RWE) and the potential use of each.  After reading the draft guidance, it seems to me that the industry is still far away from being able to rely on RWD and RWE for use in supporting initial application approval,

Big Year for NMEs at FDA

In 2018, the FDA says it approved fifty-nine new molecular entities, which included a whopping thirteen biosimilar products.  All of the NME product approvals can be found here.

It is important for you the read the FDA explanation of how the Agency is defining NMEs for the purposes of this report and stay focused on the regulatory implications versus the practical implications of how the FDA is classifying this term. 

Happy Holidays from Us to You!

To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year.  The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as we follow the ever-changing landscape of FDA regulatory science,

OGD Ties Its 128 Approval Actions Record in November Plus October Stat Update

It appears that 128 is the magic number for the OGD as last month they also had 128 approval actions.  November numbers saw a different split between full approvals and tentative approvals (99 and 29, respectively).  The 128 total approval actions obviously ties last month record number of approval actions for a single month.

Of interest,

FDA Withdraws Proposed Labeling Rule – Finally!

After just over five years, the FDA is officially withdrawing its controversial proposed labeling rule for generic drugs.  The advance publication notice in the Federal Register can be found (here).  The proposed rule would have permitted ANDA holders to unilaterally revise its labeling via a CBE-0 supplement to include new or different safety information or warnings. 

Official October OGD Numbers Are In, and Yes,  Another Record!

While we had underestimated approvals and slightly overestimated Tentative Approvals in our November 1 post (here)  on this topic, nevertheless, OGD beat the old record of 126 for total approval actions in a month by 2.  OGD fully approved 110 ANDAs and tentatively approved 18 ANDAs for a total of 128 ANDA approval actions starting off FY 2019 with a bang!

In an Unusual Move, FDA Reopens Comment Period on BE guidance for Sucralfate Suspension

While the FDA does appear to listen rather intently to comments on its bioequivalence (BE) draft guidances, and will occasionally reopen comment periods, it is still the exception rather than the rule.  Today a Federal Register (FR) notice (here) announced another sixty-day comment period during which such comments will be entertained.

2018 ISPE Pharmaceutical Manufacturing Conference, Managing the Global Pharmaceutical Supply Chain: How Pharmaceutical Quality System (PQS) Ensures Sustainable Compliance, Mumbai, India

In a time that we find ourselves so busy, who has time to attend a conference?  That was my initial thought, but when asked to speak at the conference, it became clear that this would be a unique opportunity to better understand the regulatory landscape while surrounded by members of India pharma and in the presence of key FDA regulators.  

Crowded Traffic in Beijing

No Easy Solutions for Complex Generics Yet

The Complex Generic Drug Development Workshop is currently being held in Silver Spring, Maryland September 12‑13, 2018.  In her keynote address at the FDA’s Small Business and Industry Assistance (SBIA) workshop on complex generic drug development, Kathleen Cook Uhl stated that complex drug products are critical to the care of many serious medical conditions, such as multiple sclerosis,

Medical team sitting and discussing at table

History is written by people who attend meetings: especially when it comes to complex generics

The GRx+Biosims Conference held in Baltimore, MD from September 5-7, had a session on the GDUFA II Pre-ANDA Program for Complex Products on the last day, presented by FDA.

The presenter, Kris Andre, Associate Director of Regulatory Affairs, Office of Research and Standards, Office of Generic Drugs (OGD), discussed in detail the logistics and agency’s expectations related to the meetings for complex generics.