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The US Food and Drug Administration (FDA) is asking makers of testosterone replacement therapy (TRT) products to consider submitting applications to expand the use of their products for low libido in men with idiopathic hypogonadism. The move comes after a panel of experts called for relaxing regulatory restrictions on the products to address conditions such as heart disease and diabetes.

The US Food and Drug Administration’s (FDA) has called on its Pharmacy Compounding Advisory Committee to discuss whether a dozen peptide drugs should be eligible for compounding by licensed facilities. These peptides are used to treat opioid use disorder, wound healing, insomnia, and ulcerative colitis.

European authorities have recommended changes to the regulatory framework to keep pace with the progress of the radiopharmaceutical sector.

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The US Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) has stepped up its enforcement efforts regarding prescription drug promotion, issuing three new untitled letters to Pfizer Inc., Amneal Pharmaceuticals LLC, and BioCorRx Pharmaceuticals Inc.

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The US Food and Drug Administration (FDA) has released draft guidance on how sponsors can utilize next-generation sequencing (NGS) methods in nonclinical studies to assess the safety risks associated with gene therapy products.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.