The Office of Generic Drugs updated its Generic Drugs Program Activities Report – Monthly Performance for January (here) to fill in more data on various metrics. As you know, the Agency typically comes out with the number of ANDA approval and tentative-approval actions and receipts of original ANDAs, along with the number of complete response […]
FDA has proposed some relief from the component shortages created for parenteral and other products identified in the just released Guidance entitled, COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers. The Agency has recognized the need to provide some regulatory flexibility regarding the filing type for certain changes that may be necessitated […]
On January 14, 2020, we posted a blog (here) concerning a Drug Safety Communication discussing FDA’s concern that the drug product Belviq or Belviq XR (lorcaserin) could increase the risk of cancer. On September 16, 2020, we posted a blog noting FDA’s final action withdrawing the 2 NDA drug applications for the product mentioned above […]
In a prepublication of a Federal Register notice (here) that will publish on March 3, 2021, the FDA has announced its intention to refuse to approve the 505(b)(1) NDA originally filed by Sanofi and now held by Lexicon Pharmaceuticals for Sotagliflozin Oral Tablets, 200 mg and 400 mg. The product was intended to be indicated […]
As we have seen in the news lately, the SARS-CoV-2 virus is spinning out new variants as it replicates in infected individuals. Some of these new variants have been found to be more infectious (and possibly more pathogenic) than the initial virus that first entered the human population. The good news is that the FDA […]
OGD released its official numbers for approval actions, complete response letters and ANDA original receipts for January today, as well as updating metrics for December 2020. From our unofficial numbers reported for January, we hit the numbers of full approval actions on the nose at 62, but OGD snuck in an additional tentative approval action […]
Medical Device Week, a Lachman Learning Experience™ provided a great opportunity for industry professionals to gain knowledge and insight into a range of topics critical to the medical device industry. Our initial feedback indicates that those who participated found it valuable and highly informative. One of the most important topics covered was the FDA’s focus […]
As you know, we try to track the ANDA approval actions and report on other OGD metrics as closely and as early as we can to try to give you the most current and most timely information. The one thing we have found that the generic industry, as a whole, is most interested in are […]
What engineer enjoys writing Software Development Life Cycle (SDLC) documents, such as a Software Requirements Specification or SFMEA? I have yet to meet one that has the passion to sit and document the requirements. While there are numerous purposes and reasons for documenting the requirements, the greatest value is in the process that leads up […]
We know that a regulation hold has been placed by the Biden Administration until they can review their positions on proposed regulations, but it is highly unusual that no FR notices have appeared since Inauguration Day, January 20, 2021. Many FR notices address issues other than regulations, including meeting notices, guidance announcements, collections of information […]