In two separate Federal Register notices (here for medical devices and here for outsourcing facilities), the FDA announced the user fee amounts for FY 2020. The FDA notes that the fees are effective on October 1, 2019 (the beginning of the 2020 FY) through September 30, 2020. The medical device fees are provided in the […]
In announcing the July 24th approval of Baqsimi (glucagon powder for nasal administration) (here) FDA notes that it is the first form of glucagon that can be administered without injection. The product is to be used by a caregiver or we assume someone on the street if the patient is unconscious. The product is a […]
FDA has announced the availability of another draft guidance for industry entitled, Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process. The draft guidance is part of FDA’s continued support of the Drug Competition Action Plan and to encourage the generic industry to take advantage of the USP’s Pending Monograph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 […]
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 […]
The FDA released a draft guidance today titled Submitting Documents Using Real-World Data and Real‑World Evidence to FDA for Drugs and Biologics (here) that describes how the Agency will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 After reading the draft guidance, it seems to me that […]
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 […]
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 […]
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 […]
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 […]
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 […]
