Container Closure Integrity (CCI) testing is a central aspect of contamination control for a product. Contamination control strategy begins with the design, qualification, and validation of a facility, equipment, and processes. Product containers and closures are a crucial element of contamination control. Package integrity is the ability of the package to prevent loss, maintain sterility, and maintain the internal environment (such as headspace). In 2008, the FDA issued a Guidance on Container Closure Integrity Testing (FDA Guidance Container and Closure System Integrity Testing in Lieu of St ..read more

FDA has finalized its long-awaited Final Rule on Medical Devices; Laboratory Developed Tests (here).  This Rule has been percolating within the Agency for a while and is the final step since the Proposed Rule was issued October 3, 2023.  FDA explains that since  “1976, the Medical Device Amendments of 1976 (the MDA) amended the FD&C Act to create a comprehensive system for the regulation of devices intended for human use.  In implementing the MDA, FDA has exercised enforcement discretion such that it generally has not enforced applicable requirements with respect to mos ..read more

Today, the FDA has published a new draft guidance titled Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDA (here) that describes the FDA’s current thinking on consistency of composition statements in NDAs and ANDAs.  It provides a clear and unambiguous requirement to list both the qualitative and quantitative formulation in the components and composition statements of applications as well as requirements for labeling of oral and nonoral products.  This promotes consistency within various sections of applications and al ..read more

In an April 24, 2024 article in Matrix Global Advisors, Alex Brill and Christy Robinson provide an interesting commentary on the Current and Future State of U.S. Biosimilars (here). In the article, they address a number of issues regarding the current biosimilar market and the direction it is taking. They also describe the varied uptake of various approved biosimilar products in different therapeutic areas. They note that “[F]ourteen years ago, Congress established a regulatory pathway for biosimilars, direct competitors to branded biologic drugs. To date, the Food and Drug Administration (FDA ..read more

Today, the FDA released a draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar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