Today, the FDA released a draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers (here). Try saying that without taking a breath! This draft is a revision of the initial draft guidance issued on February 4, 2020 (85 FR 6201) (the 2020 draft guidance). The pre-publication Federal Register Notice announcing the revised guidance (here) states, “In revising this guidance, FDA considered comments received on the 2020 draft guidance and expanded the s ..read more

Last week, I was able to attend SBIA’s Generic Drug Forum in Bethesda, Maryland, and I’m sure that many readers of Lachman’s blog also attended virtually. The Forum offered a diverse array of presentations applicable to the generic industry at large. In this blog, I will focus on one presentation related to PLAIRs (Pre-Launch Activities Importation Requests). The presentation itself provided some valuable insight into the flow of information within the Agency, the contents of a PLAIR, and when application sponsors should submit PLAIRs based on application type and priority status. Perhaps most ..read more

Although the pilot program for Parallel Scientific Advice (PSA) meetings with U.S. and the EMA for complex generics and hybrid products is relatively new, there have been only two requests for meeting participation thus far. According to the FDA, “The Parallel Scientific Advice (PSA) pilot program allows for applicants to engage in concurrent scientific conversation with both agencies, the FDA and the European Medicines Agency (EMA), on key issues during the development phase of complex generic drug products and hybrid products” (here). There are a couple of barriers that make this program a b ..read more

With the first half of the month in the books and postings up through April 17, 2024, the OGD has issued thirty full-approval actions and seven tentative-approval actions. At this rate, it is possible that the OGD will hit or break sixty full-approval actions in April. This could be the first month that the OGD goes over sixty final approval actions in FY 2024, with the previous high being fifty-seven in October 2023 (the first month of FY 2024). As noted previously, we are keeping a close eye on approval actions and ANDA submissions based on the lower numbers that we’ve been seeing in the las ..read more

What is the answer to the question?  Apparently, at the FDA’s Center for Drug Evaluation and Research (CDER) Small Business Industry Assistance (SBIA) Generic Drug Forum for 2024 (held April 10-11), it was Controlled Correspondence (CC).  The FDA conducted two presentations exclusively on CCs and responded with that answer on more questions than not throughout the forum, or so it seemed.  Seemingly, CCs are a great path for industry to get information.  However, as we know, CCs are not the end-all, be-all route to answers (as discussed in previous blogs here, here, here, an ..read more

At the Association of Accessible Medicines (AAM) February 2024 Annual Meeting Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director of CDER, made another interesting point in her presentation yesterday, outlining the number of national drug shortages that the FDA reported per calendar year (reproduced at the link below) and indicating that the press has reported an ever-increasing number of shortages, but the data belie that assertion (see post here). Yesterday Tina Reed at Axios reported that drug shortages have reached an all-time high (here). Ed Silverman of Stat also repo ..read more

This month we will pat ourselves on the back as we captured the correct number of approval and tentative approval actions in our calculation of the unofficial numbers in our post here. We were more patient when looking at the February data from the daily approval page (which must be pieced together because it only provides a 14-day look back and the FDA All Approvals Report page here), and correctly predicted 52 full approval actions and 11 tentative approval actions! Thus, there were 63 ANDA approval actions taken for the month. Of the February full approval actions, seven (7) were for first ..read more

As the saying goes, March came in like a lion but went out like a lamb. The OGD issued only 48 full-approval actions and 13 tentative-approval actions for a total of 61. The beginning days of the month looked relatively strong but that kind of petered out towards the end of the month. The 48 full approvals represent the lowest number of full-approval actions thus far this fiscal year, as does the total of 61 full- and tentative-approvals for the months for which official numbers have been reported this FY. (We must note that official numbers for only four months, October 2023 to January 2024 ..read more

It’s not the big things that you need to worry about; it’s the little things that will kill you! And nothing is truer than that when it comes to microbial bugs that have become resistant to antibiotic therapy! The rise in “Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. According to the Centers for Disease Control and Prevention, each year in the United States at least 2.8 million antibiotic-resistant infections occur, and more than 35,000 people die as a res ..read more

For the last several years, there has been a push in the industry to take a systematic approach and design quality into your systems and processes by establishing up front requirements such as QTPP for process validation and ATP for analytical methods. Such an approach provides invaluable benefits to the public whereby, the manufacturer has a better understanding of the critical attributes that drive quality for the manufacturing and testing of the product and the required controls for those attributes. When considering the above, one can ask whether such a concept should be applied to all of ..read more