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The US Food and Drug Administration (FDA) recently released a draft guidance that clarifies the responsibilities of new owners of 510(k) clearances when products are sold or transferred to another entity.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