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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.
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By: Ferdous Al
The US Food and Drug Administration (FDA) has issued warning letters to several drugmakers for violations of current good manufacturing practices (CGMP). The agency also issued a warning letter to a Chinese drugmaker for marketing drugs in the US without providing regulators with the critical records needed to ensure compliance.
By: Ferdous Al
Industry and academic stakeholders have asked the US Food and Drug Administration (FDA) to clarify its objectives and plans for a proposed pilot program to evaluate how artificial intelligence (AI) technologies can help improve early-phase clinical trials. They also said the agency should develop a governance structure with specific metrics and goals and consider aligning its thinking with other regulators.
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, FDA named the seven companies that will participate in its PreCheck Pilot Program and opened its total product life cycle advisory program (TAP) pilot to products overseen by all of its Offices of Health Technologies (OHT).
By: Ferdous Al
Industry groups are asking the US Food and Drug Administration (FDA) for greater transparency into its Commissioner's National Priority Voucher (CNPV) pilot, including how the agency intends to transition the pilot into a full-fledged program.
By: Ferdous Al
Industry groups are asking the US Food and Drug Administration (FDA) for greater transparency into its Commissioner's National Priority Voucher (CNPV) pilot, including how the agency intends to transition the pilot into a full-fledged program.
By: Ferdous Al
The US Food and Drug Administration (FDA) and the medtech industry have agreed to commitment letter language for the Medical Device User Fee Amendments (MDUFA VI) program for the next five fiscal years.
By: Ferdous Al
Researchers at the US Food and Drug Administration (FDA) recently conducted a study in response to a 2024 study that raised safety concerns about metal toxicity from tampons; however, the study found that the potential leaching of metals from tampon usage in even the most conservative conditions was negligible.
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, there were reports that the Trump Administration is reviewing candidates to head FDA, FDA was pressured to pause publishing complete response letters (CRL), and more.
By: Ferdous Al
The US Food and Drug Administration (FDA) has finalized its guidance on clinical trial requirements for developing psychedelic therapies. The final version clarifies the agency's thinking, based on industry feedback, especially regarding clinical and safety considerations in the design of clinical trials.
By: Ferdous Al-Faruque
Industry experts say the draft commitment letter for the next Medical Device User Fee Amendments (MDUFA VI) program negotiated by the US Food and Drug Administration (FDA) and the medtech industry offers improvements over the current program while addressing the agency's resource constraints.
