News & Insights Search

Companies that invest in quality management initiatives can incur lower costs related to defects, waste, and recalls compared to those that do not make such investments, according to a white paper published by the US Food and Drug Administration's (FDA) Office of Pharmaceutical Quality (OPQ) on Tuesday.

Two pharmaceutical industry representatives told the House Energy and Commerce Health subcommittee on Wednesday that offering tax credits and long-term purchasing commitments to domestic pharmaceutical manufacturers would enhance the US manufacturing base.

The US Food and Drug Administration (FDA) recently released a draft guidance that clarifies the responsibilities of new owners of 510(k) clearances when products are sold or transferred to another entity.

Pharmaceutical industry groups in the EU are requesting more information on how to conduct decentralized trials to encourage their adoption. They also emphasized the need for clearer guidelines on informed consent in decentralized trials within the International Council for Harmonisation's (ICH) draft E6(R3) Annex 2 guideline on good clinical practice (GCP).

The European Medicines Agency (EMA) has published work plans for its Infectious Disease Working Party (IDWP) and Oncology Working Party (OMCWP), outlining the actions these groups will undertake over the next three years.

The European Commission is asking for stakeholder input on a plan to allow electronic medical device instructions for use (eIFU) be provided to healthcare providers for all devices, not just high-risk products. The consultation was released on 21 February and stakeholders have a month to provide feedback.

The Trump Administration's return-to-office mandate for federal employees, which also limits the hiring of remote workers, will restrict the US Food and Drug Administration's (FDA) talent pool and weaken the agency, according to Wilson Bryan, who served as the director of FDA's Office of Tissues and Advanced Therapies from 2016 until his retirement from the agency in 2023.

Recent mass layoffs at the US Food and Drug Administrations (FDA) by the Trump Administration will hinder the agency's reviews of new devices and result in the agency failing to meet the user fee goals outlined in the Medical Device User Fee Act (MDUFA), according to legal experts who spoke to Focus.

BARCELONA – A European Medicines Agency (EMA) official provided an update on the agency's pilot programs aimed delivering scientific advice to manufacturers of high-risk and orphan medical devices to support the clinical development of such products.

LONG BEACH, CA – The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) saw a decrease in the number of clinical holds placed on biological products in recent years, thanks to early engagement with sponsors and other efforts by the center.

The European Medicines Agency (EMA) on 9 September proposes updating its guideline on developing drugs for treating bipolar disorder (BD) to reflect new medical understanding of the disease.

WASHINGTON – US Food and Drug Administration's (FDA) officials say they are aware of industry's concerns about complying with the track and trace requirements of the Drug Supply Chain and Security Act (DSCSA) yet insist that the agency will stick to its 27 November 2024 implementation timeline. They also urged experienced companies who have track and trace systems in place to assist those with less experience at a 27 August meeting sponsored by the Healthcare Distribution Alliance (HDA).

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) last Friday announced that effective next October 2025, medical device manufacturers will have to use the electronic Submission Resource and Resource (eSTAR) template for submitting de novo applications.

The US Food and Drug Administration (FDA) on Thursday finalized guidance to assist sponsors in finding the right dosage for the newer class of cancer drugs. The agency announced that the update stresses there is no 'one size fits all approach” in dosing for these drugs.

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) on Monday announced it has elevated its communication office to a new 'super office” as part of a move to increase its organizational agility and enable the center to meet its Medical Device User Fee Amendments (MDUFA) V goals as well as its strategic priorities for 2022-2025.