Ferdous Al-Faruque is a Senior Editor at Regulatory Focus. He specializes in medicine and healthcare, with a particular focus on healthcare technology, pharmaceuticals, and medical specialties, while also covering topics like immunology, oncology, and gene therapy. Ferdous is featured in the Regulatory Affairs Professionals Society (RAPS).
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Ferdous Al-Faruque's coverage heavily focuses on legal policy regulation and government announcements within the healthcare and pharmaceutical industries, particularly in relation to FDA regulations and compliance. He would likely be receptive to pitches from experts who can provide insights into regulatory changes, compliance trends, or the impact of new policies on medical technology companies.
Given Ferdous' focus on detailed regulatory developments and industry-specific topics such as AI/ML in the medtech industry, he is more likely to engage with sources who have direct experience with FDA regulations or are deeply knowledgeable about specific compliance issues within the healthcare and pharmaceutical sectors.
It's important for potential sources reaching out to Ferdous Al-Faruque to be able to provide expert commentary supported by reliable data related to FDA regulations, medical technology advancements, or regulatory guidance within these industries.
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By: Ferdous Al-Faruque
LISBON – A panel of experts at RAPS Euro Convergence 2026 discussed how artificial intelligence (AI) is being applied throughout the product lifecycle, from compiling premarket application submissions to assisting in the conduct of conformity assessments.
By: Ferdous Al-Faruque
Industry groups and legal experts want the US Food and Drug Administration (FDA) to make significant revisions to a proposed guidance on how pharmaceutical manufacturers should address Form 483 observations after a current good manufacturing practice (CGMP) inspection.
By: Ferdous Al
The US Food and Drug Administration (FDA) has issued warning letters to two researchers for failing to meet good clinical practice (GCP) requirements and for not complying with their own trial protocols. The agency also cited several drug manufacturers for failing to adhere to current good manufacturing practices (CGMP).
By: Ferdous Al
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.
By: Ferdous Al
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, we learned that there has been a major culling of top FDA leadership, the drug user fee negotiations have ended, the agency’s vaccine panel will evaluate Moderna’s flu vaccine, and more.
By: Ferdous Al-Faruque
The European Commission has published an analysis detailing the benefits of enacting the European Biotech Act, which was proposed last year as a means of increasing the EU's competitiveness in the sector, in part by simplifying regulations.
By: Ferdous Al
The US Food and Drug Administration (FDA) has finalized a revised draft guidance from 2022 on what human factors (HF) information sponsors should include in premarket submissions for medical devices.
By: Ferdous Al-Faruque
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 HHS said several of former FDA Commissioner Marty Makary's initiatives would continue to be implemented at the agency, the device center celebrated 50 years of the law that created the modern medtech regulatory framework, and more.
By: Ferdous Al
The US Food and Drug Administration (FDA) has proposed guidance to reduce the need for animal testing in the development of oncology drugs as part of its broader efforts to reduce animal testing in drug development.
By: Ferdous Al-Faruque
The US Food and Drug Administration (FDA) has proposed guidance on the types of scientifically valid prior knowledge sponsors should consider when developing certain gene therapies (GT). The agency said the recommendations in the guidance are intended to improve review efficiency and help accelerate product development.
