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Under EU law, active pharmaceutical ingredients (APIs) shipped from India and other non-listed countries must be supported by a written confirmation certificate stating the product meets good manufacturing practices.

The US Food and Drug Administration (FDA) has warned an oncology drug company for repeatedly overstating the efficacy of its drug in advertisements while failing to adequately disclose the associated risks. The agency also issued several warning letters to companies for violations of current good manufacturing practices (CGMP) and for marketing products for non-approved indications.

Top European officials said they are optimistic that amendments to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) will be enacted quickly, but the amendments must also comply with legislative requirements, which will take several months.

The US Food and Drug Administration (FDA) and the medtech industry have reached agreement on several key areas as they negotiate the next iteration of the Medical Device User Fee Amendments (MDUFA VI) program. Among the areas of agreement is using the next round of fees to fund upgrades to the agency's IT systems and changes to its de novo and pre-submission programs.

The International Medical Device Regulators Forum (IMDRF) has published two new documents to help regulators and sponsors harmonize adverse event terminology and support regulatory reliance across regulatory agencies. The international group stated that regulatory reliance may help streamline activities by leveraging trusted regulatory authorities and that harmonizing adverse event terminology can help regulators detect safety signals sooner.

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is requesting feedback on a proposal to allow EU CE-marked medical devices sold in Great Britain to be recognized and sold indefinitely. This measure aims to ensure a continuous and uninterrupted supply of these devices. The announcement was made as part of a targeted consultation on Monday.

The US Food and Drug Administration (FDA) has issued several recent warning letters to companies, including for failing to comply with current good manufacturing practices (CGMP), marketing unauthorized products, and failing to obtain proper informed consent from trial participants.

The Central Drugs Standard Control Organization (CDSCO) has started a consultation on guidance about importing in vitro diagnostics (IVDs) into India.

BRUSSELS – The European Commission's proposed revisions to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) include specific changes to the regulation of medical device software, including medical device artificial intelligence (AI), in Europe. According to experts who spoke at the 2026 DIA-RAPS Combination Products in the EU conference, the proposed changes would clarify how the products are classified and could delay the implementation of the EU Artificial Intelligence (AI) Act.

Medical device makers must comply with the US Food and Drug Administration's (FDA) Quality Management System Regulation (QMSR) after the rule took effect on Monday. Additionally, FDA inspections of device facilities will no longer be conducted under the prior Quality System Inspection Technique (QSIT) and instead will be carried out in accordance with a new compliance program manual.

BRUSSELS – European Commission officials say they have proposed legislative changes to the European Parliament that they hope will ease regulatory requirements for sponsors of combined studies based on ongoing pilot projects.

BRUSSELS – While the European Union is undergoing major reforms to its regulation of medical devices, diagnostics, and drugs, an industry representative said there are still challenges and that more actions to streamline regulations and reduce the burden on industry are needed.

BRUSSELS – Experts from the European Commission shed light on the proposed wide-ranging changes to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) that have been put forth to the European Council and European Parliament for adoption. They say the changes are intended to address shortcomings in the legislation that have significantly delayed their full adoption over the past few years.

The US Food and Drug Administration (FDA) has cited several companies for marketing human immunodeficiency virus (HIV) serological diagnostic dried blood spot (DBS) card self-collection kits without a marketing authorization. It also cited a nutritional supplement company for conducting an unauthorized clinical trial, and a drugmaker for failing to comply with current good manufacturing practices (CGMP).

More than half of medical device companies in the EU have reduced their product portfolios to cope with the complexities of the EU Medical Device Regulation (MDR) and EU In Vitro Diagnostic Regulation (IVDR), while 17% have stopped producing devices entirely due to high certification costs and administrative burden.

Swissmedic and its public services personnel unions have reached an agreement on a plan to cut staff and save money over the next two years, a move the regulator announced last year after a significant drop in revenue.

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 updated two guidances aimed at reducing oversight of digital health products and published meeting minutes from its user fee negotiations.

The European Commission's Medical Device Coordination Group (MDCG) has outlined the postmarket surveillance (PMS) requirements that medical device and in vitro diagnostic makers should adhere to as part of their quality management system (QMS). The requirements are based on provisions in the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

In a move meant to bolster the adoption of artificial intelligence (AI)-enabled digital health products, the US Food and Drug Administration (FDA) on Tuesday updated two guidances to ease its oversight of general wellness devices and clinical decision support (CDS) software.

The International Medical Device Regulators Forum (IMDRF) has outlined its vision for the next five years, which includes further engagement with the medtech industry to ensure promising products reach patients quickly. The group also plans to reform its governance structure as it continues to grow its membership to ensure long-term sustainability.