FDA Suggests Collecting data on Ovarian Toxicity in Cancer Drug Trials
The US Food and Drug Administration (FDA) is recommending that sponsors include the collection of data on ovarian toxicity in the development of cancer drugs.
FDA Proposes Removing Oral Phenylephrine as Active Ingredient in OTC Nasal Decongestants After Review
In November 2024 the Food and Drug Administration announced its proposal to remove phenylephrine from the approved list of over-the-counter drugs to treat nasal congestion, citing evidence that the oral version of the drug is ineffective.
Industry Pushback on : Biosimilar, Biological medicines Industry, Food and Drug Administration, Generic Drug
The U.S. Food and Drug Administration (FDA) recently proposed issuing biosimilar product-specific guidance to streamline the approval process for biosimilars. While this move aims to make the pathway for biosimilar approvals more predictable and accessible, it has faced pushback from the pharmaceutical industry. Many industry leaders argue that this approach could inadvertently hinder innovation, increase regulatory burdens, and complicate the pathway to biosimilar market entry.
Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA
Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA. The Generic Drug User Fee Amendments (GDUFA) provides a framework for improving the efficiency and transparency of the review process for generic drug applications, known as Abbreviated New Drug Applications (ANDAs). One key aspect of this framework is the review of Drug Master Files (DMFs), which are critical for ANDA submissions involving drug substances, intermediates, or excipients that are not fully described in the ANDA itself.
US FDA Publication on Integrating Artificial Intelligence into Healthcare Product Copy
On March 2024, the FDA released its latest publication titled “Collaborative Efforts: Harnessing Artificial Intelligence in Medical Products,” shedding light on the concerted actions undertaken by CBER, CDER, CDRH, and OCP in navigating the landscape of AI integration within the medical product realm. This comprehensive document delineates strategic focal points essential for advancing the application of AI throughout the entire lifecycle of medical products.
” FDA determines that Medical Device Registrations must be submitted electronically from October 2025″
In August 2024, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced that starting in October 2025, medical device manufacturers must use the eSTAR (Electronic Submission Template and Resource) model for submitting new registration applications.
Modifications to Container Closure Systems: Glass Vials and Stoppers
The FDA is providing this guidance to compile recommendations for the appropriate reporting categories and the content of post approval change submissions from various FDA guidance documents.
“Electronic Submission Now Available for Investigational New Drug Application (IND) Safety Reports”
The FDA has issued a reminder to drug sponsors and researchers regarding its recent publication of guidance outlining the process for electronically submitting investigational new drug application (IND) safety reports to the FDA Adverse Event Reporting System (FAERS). IND individual case safety reports (ICSRs) can now be submitted electronically through either the Electronic Submission Gateway in ICH E2B (R3) format or via the Safety Reporting Portal, with the FDA now accepting such submissions.
US FDA Publication on Integrating Artificial Intelligence into Healthcare Product
On March 2024, the FDA released its latest publication titled “Collaborative Efforts: Harnessing Artificial Intelligence in Medical Products,” shedding light on the concerted actions undertaken by CBER, CDER, CDRH, and OCP in navigating the landscape of AI integration within the medical product realm. This comprehensive document delineates strategic focal points essential for advancing the application of AI throughout the entire lifecycle of medical products.
Annual Updates on Labeling Changes for NDAs and ANDAs Regarding Nonprescription Medications
On March 2024, the FDA is releasing a draft guidance for industry that, once finalized, will offer suggestions to holders of approved New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) for nonprescription drug products on how to document minor labeling changes in their subsequent annual reports.
The USFDA publishes tools to facilitate the registration of cosmetic product listing and facilities
In January 2024, the US FDA announced the availability of SPL Xforms, a structured product label (SPL) authoring tool intended for the registration of cosmetic product facilities and the listing of cosmetic products, as required by the Modernization of Cosmetics Regulation Act (MoCRA).
USFDA Publishes updated definitions FOR ‘Face-to-Face Meeting’
The FDA publishes updated Definitions of Face‑to‑Face Formal Meetings.