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ARLINGTON, VA – A US Food and Drug Administration (FDA) official acknowledged significant regulatory hurdles in the development of products for ultra-rare diseases, necessitating the agency’s recently proposed plausible mechanism framework.

The US Food and Drug Administration (FDA) has released draft guidance on how sponsors can utilize next-generation sequencing (NGS) methods in nonclinical studies to assess the safety risks associated with gene therapy products. This guidance aims to support the submission of investigational new drug applications (INDs) and biologics license applications (BLAs).

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

ARLINGTON, VA – The top drug regulator at the US Food and Drug Administration (FDA) said the agency is working to develop new pathways for rare diseases to reduce regulatory barriers for medical products and emphasized the need to challenge medical dogma.

The US Food and Drug Administration (FDA) has notified more than 2,200 medical product manufacturers and researchers to disclose clinical trial results as required by law. The agency said it is part of its risk-based efforts to encourage relevant parties to act before it potentially decides to take regulatory action.

The International Medical Device Regulators Forum (IMDRF) has released a draft technical document to create a harmonized set of best practices in mitigating risks associated with the use of artificial intelligence (AI)-enabled medical devices throughout their product life cycle.

Indian lawmakers have voted to decriminalize some compliance breaches to reduce regulatory litigation burden, eliminating the potential for prison sentences while increasing monetary fines.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

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, the FDA presented its proposed budget to Congress, the agency rejected a petition for a partial 510(k) exemption for certain software products, and former top CDRH officials launched a venture capital firm.

The International Council on Harmonization (ICH) E22 guideline should incorporate caregiver feedback, according to responses submitted by industry groups and manufacturers to a US Food and Drug Administration public consultation.

Many of the bispecific antibodies (BsAbs) approved by global regulators have yet to demonstrate robust clinical benefit beyond surrogate endpoints that led to their initial approval, according to research published in BioDrugs.

US Food and Drug Administration (FDA) officials credited recent advancements in regulatory science and flexibilities with enabling growth in the cell and gene therapy sector during a meeting on Thursday; however, a cell therapy expert said there is still reluctance from FDA and industry to enroll pediatric patients in clinical trials for such treatments.