This Week at FDA: FDA names PreCheck participants, TAP open to all OHT devices, and more
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, FDA named the seven companies that will participate in its PreCheck Pilot Program and opened its total product life cycle advisory program (TAP) pilot to products overseen by all of its Offices of Health Technologies (OHT).
FDA announced that seven companies will participate in its PreCheck Pilot Program, intended to help new drugs and biologics manufactured in the US come to market sooner by allowing earlier engagement with regulators and creating more predictability in the regulatory process. The companies include Amneal Pharmaceutical, Cellares, Eli Lilly, FUJIFILM Biotechnologies, Kriya Therapeutics, Kyowa Kirin, and Regeneron Pharmaceuticals.
“By making our regulatory processes and expectations more transparent, we ensure that American pharmaceutical manufacturers remain global leaders while securely providing high-quality treatments to patients right here at home,” said Acting FDA Commissioner Kyle Diamantas.
On Wednesday, FDA announced that 133 devices have been enrolled in its TAP pilot. The agency also said that the pilot has been expanded to all breakthrough-designated and Safer Technologies Program (STeP) devices across all Offices of Health Technologies (OHTs) that meet the TAP enrollment criteria.
STAT News reported that FDA has published the names of eight new panelists to serve on its Pharmacy Compounding Advisory Committee, the majority of whom are involved with businesses that promote and prescribe peptides, which have been touted by Kennedy for various health purposes. The agency is set to meet for two days, starting on 23 July, to discuss adding several peptides to the list of drugs eligible for bulk compounding. In briefing materials posted to the agency’s website this week, FDA staff raised concerns about potential safety issues and the lack of evidence supporting the molecules’ use.
As global public health officials tackle the ongoing Ebola crisis, FDA has updated a 2017 level 2 final guidance on assessing blood donor eligibility, donor deferral, and blood product management in the event of an Ebola disease outbreak. While the original guidance was developed in response to the 2014 Ebola virus (Orthoebolavirus zairense), the agency expects its recommendations to apply to all Orthoebolaviruses that cause Ebola disease in humans during an Ebola outbreak.
FDA also updated its guidance on submitting next-generation sequencing protocols, data, and analyses of resistance assessments when developing antiviral drugs. The agency said it wants to ensure drug resistance is adequately characterized and explained in antiviral drug labeling.
Health and Human Services Secretary Robert Kennedy Jr. signed an order terminating COVID-19 emergency use authorization (EUA) declarations for drugs, biologics, and medical devices, stating that the agency was "reinforcing public confidence that emergency authorities are temporary and targeted." Drug and biologics EUAs will terminate in one year, while medical device EUAs have 180 days before termination.
Drugs & biologics
External experts from FDA's Cellular, Tissue, and Gene Therapies Advisory Committee are set to meet virtually on 29 July to discuss whether to recommend Capricor's BLA for deramiocel (human allogeneic cardiosphere-derived cells) to treat cardiomyopathy in patients with Duchenne muscular dystrophy (DMD). Stakeholders can comment on the application until 28 July on www.regulations.gov under docket no. FDA-2026-N-6771.
FDA approved Orca Biosystems' biologics license application (BLA) for Tregzi as the first regulatory T cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult patients with blood cancers undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). The novel treatment infuses stem cells and immune cells from a closely matched donor, helping the recipient's immune system fight cancer while reducing the risk of chronic GVHD, in which donor blood cells attack the patient's body.
The agency also approved Vertex Pharmaceuticals’ supplemental BLA for Casgevy (exagamglogene autotemcel) to treat patients 2 years and older with sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) or transfusion-dependent β thalassemia (TDT). The agency noted it is the first such treatment for patients that young, which had previously been approved for patients 12 years and older.
Medtech
FDA has published a page on clinical decision support (CDS) software providing resources and answering frequently asked questions. The agency noted that, while the 21st Century Cures Act excluded some CDS from regulatory oversight, other such software may still fall within the definition of a medical device that requires marketing authorization from the agency.
FDA two types of devices this week into class II with special controls, including skin patches to treat hyperhidrosis. Some of the mitigating steps required by the agency include clinical, non-clinical, performance, shelf-life, and thermal-safety testing, as well as biocompatibility evaluations and labeling updates.
The agency also classified monitors for opioid induced impairment of oxygenation into class II with special controls. Similarly, the agency has asked for mitigation measures, including requiring clinical performance data; non-clinical performance testing, biocompatibility evaluation, and labeling updates.
Hologic has initiated a Class I recall according to FDA for its BioZorb Marker and BioZorb LP Marker due to reports of complications and adverse events associated with the implanted devices, resulting in 252 reported injuries to date. The company has asked users to stop implanting the devices, and to monitor patients who have already had the devices implanted.
FDA published a list of products that it says have shown potential safety signals from the Adverse Event Monitoring System (AEMS). The agency listed 20 events that it analyzed in the first quarter of the year and said that, in most cases, it is still evaluating the need for regulatory action.
