One of the breakout sessions offered at the recent FDLI conference was titled, Updates on Patent and Exclusivity Issues for Drugs, Orphan Drugs and Biologics. The panel for this session included representatives from FDA, industry, and attorneys that specialize in this practice area. While the session covered both patent and exclusivity issues, I will be […]
Hundreds of FDA staff, industry professionals, lawyers, and others gathered in Washington, D.C. on May 17th and 18th to participate in the 2023 Food and Drug Law Institute (FDLI) Annual Conference. The agenda covered a broad range of current regulatory and legal issues facing the food, drug, medical device, biologics, and tobacco industries. Lachman Consultant Services […]
In the prepublication of the Federal Register (here) which will publish on May 15, 2023, the FDA announced that Makena (Hydroxyprogesterone Caproate injection) will be removed from the Orange Book (OB) along with eight (8) generic applications that referenced Makena as the RLD in its application. Makena was originally approved in 2011 under the accelerate […]
Based on the longstanding knowledge that diethylene glycol (DEG) and ethylene glycol (EG) are dangerous at levels that may exceed USP‑NF limits and because of the recent misadventures and deaths resulting from these incidents, the FDA has revised a 2007 guidance to provide further recommendations regarding the identification and quantification of these contaminants in drug […]
The monitoring of clinical studies is extremely important to protect the rights, welfare and safety of the study participants, and to assure the integrity of the study data submitted to the FDA and thus, ultimately the accuracy of FDA’s evaluation of submitted studies and subsequent approval decisions. If you have been following the debarment notifications […]
The FDA is updating the draft guidance entitled, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, that originally issued in March of 2020. As the drug shortage problem continues, this revised guidance (see here) is to better assist applicants and manufacturers in a process to provide […]
It is always interesting to see how the Agency works when one action could trigger another action. In the Federal Register pre-publication page (here) this morning, the “Food and Drug Administration (FDA) [announced that it] is withdrawing approval of new drug application (NDA) 019832 for SULFAMYLON® (Mafenide Acetate, USP) Powder for 5% Topical Solution, held […]
The opioid/fentanyl crisis, along with the abuse of other opioid‑based products, has put the prospect of an over‑the‑counter (OTC) version of naloxone high on the FDA’s priority list. Making the product available in a ready and easy‑to‑use format (for instance, a nasal spray or autoinjector) would increase the availability of this potentially life‑saving drug. Now, […]
I recently attended the ISPE Annual Meeting, held October 29 through November 2, 2022 in Orlando, Florida. The conference had varied content in areas such as Digital Transformation, Manufacturing Trends, Regulatory and Quality, Supply Chain Optimization, and Therapy Innovations. The conference was well attended by both industry and regulators. Although I found all of the […]
At the first highly attended ISPE Annual meeting since the pandemic hit, the themes that kept emerging from both sessions and attendees was convergence and collaboration. This concept reached its peak at the sessions that ended this conference, with a keynote from Peter Marks, MD/PhD, Director, CBER, FDA, the Regulatory Town Hall featuring representation from […]
