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Ferdous Al's coverage primarily revolves around health-related government announcements, legal policy regulations, and press releases. He focuses on the United States and is particularly interested in FDA regulations and medical devices.
To effectively reach out to Ferdous, consider providing insights or expert commentary on proposed legislation related to diagnostics or any developments within the FDA regarding medical device approvals. Since he covers a significant portion of government announcements and legal policy regulation, experts with knowledge of these areas would likely capture his attention.
Given that Ferdous' geographic focus is national (United States) and his articles often involve U.S. lawmakers proposing bills or FDA draft guidance updates, it would be beneficial for pitches to align closely with domestic regulatory issues within the healthcare sector.
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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
The US Food and Drug Administration has updated its draft guidance on how the drug and medical device makers should communicate with payors and other stakeholders about their products. The updates are intended to reflect provisions in the 2023 Consolidated Appropriations Act.
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, the Trump administration is reviewing candidates for FDA commissioner, the agency is trying to repair relations with the rare disease community, and Vanda will have an opportunity to defend its jet lag drug at a public hearing next month.
