This Week at FDA: CDER’s AI Council, Novavax’s updated COVID vaccine authorized, 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’s Center for Drug Evaluation and Research (CDER) announced it is consolidating its artificial intelligence (AI) efforts under one central council, FDA authorized an updated version of Novavax’s COVID-19 vaccine, and the agency’s device center cleared the first automated insulin delivery system software for type 2 diabetes.

Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research (CDER), sent out an all-staff email this week announcing the creation of the CDER AI Council. She noted the council will consolidate the work of the CDER AI Steering Committee, AI Policy Working Group, and CDER AI Community of Practice, all of which will be sunset when the new council is launched.

Cavazzoni said the council meets the requirements set by President Joe Biden's Executive Order (EO) 14110 to promote the safe, secure, and trustworthy development of AI technologies and a follow-up memorandum from the Office of Management and Budget. While all CDER offices will be represented on the council, it will be co-led by Sri Mantha from the Office of Strategic Programs, Tala Fakhouri from the Office of Medical Policy, and Qi Liu from the Office of Translational Sciences.

"While multiple CDER groups have previously been involved in AI initiatives spanning policy, regulatory, and technology efforts, the changing external and federal environments for AI have brought new governance needs," said Cavazzoni. "The advent of novel AI applications, such as generative AI and large language models, is likely to expand opportunities for use of AI within CDER, including by non-technical staff."

"This will require increased AI education and coordination," she added. "There has also been a rapid increase in CDER regulatory submissions incorporating AI, and the scope and impact of AI use in drug development are expanding."

Cavazzoni noted that the AI Council will conduct an inventory of all CDER AI projects, expand tracking of AI efforts in CDER, and establish a centralized process for future AI project consultations.

After approving and authorizing updated versions of Pfizer and Moderna’s mRNA vaccines targeting the Omicron KP.2 strain, FDA has also now granted the amended emergency use authorization (EUA) for Novavax's Novavax COVID-19 vaccine. The updated vaccine includes a monovalent component of the Omicron JN.1 strain of the SARS-CoV-2 virus for use during the 2024-2025 COVID-19 season.

The Center for Devices and Radiological Health (CDRH) announced that it had expanded the indication of Insulet's SmartAdjust software used on the company's Omnipod 5 automated insulin delivery system for adults with type 2 diabetes making it the first such cleared product. The technology had already been cleared for patients two years and older with type 1 diabetes.

External experts on FDA's Patient Engagement Advisory Committee (PEAC) are scheduled to meet on 30 October to discuss patient-centered informed consent in clinical studies. They will be asked to advise the agency on the informed consent process and how to improve patient informed consent forms that it says are often very lengthy and difficult to understand.

Drugs & Biologics

CDER and Center for Biologics Evaluation and Research (CBER) have issued a request for information (RFI) to get stakeholder feedback on how to advance model-informed drug development (MIDD). More specifically, the centers want to know how to increase the use of MIDD approaches in regulatory decision-making and how drug development efforts are incorporating MIDD. Stakeholders have until 2 November to offer feedback, which the agency may use to develop guidance.

In partnership with the Reagan-Udall Foundation, FDA is hosting a hybrid public meeting on 6 September on advancing treatments for post-traumatic stress disorder (PTSD). The meeting will include discussions on accelerating treatments for PTSD, including the development of psychedelic drugs.

FDA is hosting a two-day public workshop on scientific and regulatory considerations when assessing immunogenicity risks for generic peptide and oligonucleotide drugs starting on 7 October. Stakeholders representing regulators, industry, and academia will have the chance to discuss strategies, potential risks, reference standard selection, and statistical approaches when assessing peptide and oligonucleotide drugs.

External experts on FDA's Pharmacy Compounding Advisory Committee are scheduled to meet in-person on 29 October and then again on 4 December to discuss including several bulk drug substances on the 503A Bulks List. The list includes substances that comply with regulatory requirements that allow state-licensed physicians and pharmacists to use them when making compound drugs.

CBER announced the approval of several supplemental biologics license applications (sBLA), including Emergent Biosolution's Vaccinia (smallpox and Mpox live) vaccine for Mpox. The vaccine was already licensed to treat smallpox, but this week, FDA expanded the indication to also vaccinate for MPox, making it the second vaccine for Mpox after Bavarian Nordic’s Jynneos vaccine.

CBER also signed off sBLAs for arthroscopic delivery of Vericel's MACI (autologous cultured chondrocytes on porcine collagen membrane) to repair certain cartilage defects of the knee, and extended the current in-use hold time for Sarepta's Elevidys (delandistrogene moxeparvovec-rokl) used to treat Duchenne muscular dystrophy (DMD).

Medtech

In March 2023, FDA finalized a rule updating its mammography regulations under the 1992 Mammography Quality Standards Act (MQSA) that will go into effect on 10 September. This week, the agency published a notice that it has amended the final rule and has decided to withdraw two standards and amend another referenced in the rule.

The rule addresses issues such as mammography standards for accreditation bodies, regulations around mammography equipment, quality assurance testing, and that mammography facilities provide certain breast density information to patients and their healthcare providers. Alongside the rule, FDA also published a small entity compliance guide (SECG) guidance to help smaller manufacturers comply with the MQSA rule.

Geneoscopy's premarket approval application (PMA) for its ColoSense laboratory test, which measures ribonucleic acid (RNA) and hemoglobin (blood) in human stool to diagnose colorectal cancer or advanced adenomas, was approved. Patients who are 45 and older can take stool samples at home and send them to qualified laboratories for processing and testing.

CDRH is holding another virtual medical device sterilization town hall on 11 September to address helping manufacturers reduce the use of ethylene oxide (ETO) to sterilize their products. During the meeting, the agency plans to discuss sterility master files and how to effectively use them in premarket submissions.

This Week at FDA: CDER’s AI Council, Novavax’s updated COVID vaccine authorized, and more

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