Latest Regulatory Updates

The FDA announced the granting of two National Priority Review (NPR) vouchers to incentivize the development of drugs for neglected tropical diseases and rare pediatric diseases.

The FDA is announcing a new contracting approach, utilizing Other Transaction Authorities (OTAs), to foster public health innovation and collaboration with external partners for drug development and regulatory science advancements.

This consultation proposes new regulations requiring pharmaceutical companies to disclose payments made to healthcare professionals in the UK, aiming to increase transparency and address potential conflicts of interest.

The MHRA has launched a call for evidence to inform the development of a proportionate and adaptable regulatory framework for artificial intelligence (AI) in healthcare, seeking input from stakeholders on how AI technologies should be regulated to ensure safety, efficacy, and ethical considerations are addressed.

Following an investigation into an infant botulism outbreak linked to ByHeart Infant Formula, the FDA is issuing draft guidance and requesting public comment on improvements to recall effectiveness, including enhanced communication strategies and standardized data reporting.

The FDA announced a final guidance that eliminates a previous restriction, allowing for greater use of real-world data and evidence in drug and device application reviews to support regulatory decision-making.

The FDA proactively awarded a National Priority Voucher, intended to incentivize the development of new drugs, based on strong results from a Phase 3 clinical trial for daratumumab.

The FDA approved two oral therapies, amoxicillin and cefixime, as treatments for uncomplicated gonorrhea in adults and adolescents with a body weight of at least 45 kg, marking the first new gonorrhea treatment approvals in over a decade.

The FDA is proposing to add five ingredients to the list of sunscreen active ingredients that are GRASE (Generally Recognized As Safe and Effective) for over-the-counter drug products, allowing manufacturers to seek approval to market sunscreens containing these substances.

The ICH has published recommendations outlining areas for future guideline development related to advanced therapy medicinal products (ATMPs), focusing on topics such as gene therapies, cell therapies, and tissue-engineered products to harmonize global regulatory approaches.

The FDA approved Strimvelis, the first gene therapy treatment for Wiskott-Aldrich syndrome, a rare genetic disorder primarily affecting children.

The FDA approved the first application utilizing a Commissioner's National Priority Voucher, incentivizing domestic manufacturing capacity for antibiotic drugs and supporting efforts to strengthen supply chain resilience.

This consultation proposes changes to the National Institute for Health and Care Excellence (NICE) regulations, specifically addressing the cost-effectiveness threshold used in assessing innovative medicines and technologies.

The FDA approved the first cellular therapy, designed for patients with severe aplastic anemia, marking a significant advancement in treatment options for this rare and life-threatening condition.

The FDA has launched TEMPO, a pilot program designed to streamline the review of digital health technologies for chronic diseases and expand patient access to these innovative tools.

The FDA approved the first CAR T-cell therapy, Brexucabtagene autoleucel (Tecartus), for adult patients with relapsed or refractory marginal zone lymphoma after two or more lines of systemic therapy.

The FDA has conditionally approved a new topical drug, Acticon XLR, for use in cattle to control New World screwworm and cattle fever ticks, requiring continued effectiveness data submission.

The FDA announced appointments of key leaders to the Center for Drug Evaluation and Research (CDER), including a new Director, Deputy Director, and Directors for several divisions.

The ICH Assembly announced the admission of new members and observers, expanding its global network for harmonized technical requirements for pharmaceuticals.

The International Council for Harmonisation (ICH) announced that its Assembly Meeting will be held in Singapore in 2025 to discuss and advance international harmonization of technical requirements for pharmaceuticals.