FDA posted a digital catalogue of nearly 1,000 historical documents pertaining to monograph drugs: https://lnkd.in/gfj8xgt7 This catalogue includes a list of documents that were only accessible as paper documents prior to the passage of the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
CDER Small Business and Industry Assistance (SBIA)
Pharmaceutical Manufacturing
Silver Spring, MD 52,584 followers
FDA’s information and training source for the regulated pharmaceutical industry
About us
FDA’s information source for small pharmaceutical business and industry; CDER SBIA educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
- Website
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http://www.fda.gov/cdersbia
External link for CDER Small Business and Industry Assistance (SBIA)
- Industry
- Pharmaceutical Manufacturing
- Company size
- 5,001-10,000 employees
- Headquarters
- Silver Spring, MD
Updates
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📣 Tomorrow! Join SBIA January 22 for BsUFA III Regulatory Science Pilot Program: Progress Update webinar The agenda includes a recap of the activities of regulatory science pilot program from the last engagement that occurred on October 16, 2023. The webinar will include a status update on the programs current research portfolio as it relates to the BsUFA III commitments as well as presentations and panel discussions by FDA staff. There's still time to register! ➡️ https://lnkd.in/euKDyYMj
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📣 Special room rates still available! Join SBIA April 9-10 for Annual Generic Drugs Forum (GDF) 2025 Register to learn from FDA subject matter experts on every aspect of the pre-ANDA and ANDA assessment programs, offering unparalleled insights and guidance. Will you join us? ➡️ https://lnkd.in/erduFaEQ 🗓️ Special room rates available until March 11! https://lnkd.in/dBa2rwTS
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CDER Small Business and Industry Assistance (SBIA) reposted this
FDA published a Federal Register Notice in which OGD announced the establishment of a public docket regarding the use of a Type V drug master file (DMF) for model master file (MMF) submissions to support abbreviated new drug applications (ANDAs): https://lnkd.in/e-bR_PeC FDA recognizes the evolving role model-integrated evidence (MIE) plays in generic drug development and other regulatory applications, as well as industry’s corollary desire for an improved framework for in silico model-sharing, model acceptance, and related communication with and submission to the agency. Use of the Type V DMF to efficiently leverage MMFs within the scope of successful MIE approaches (for example, to support alternative bioequivalence (BE) approaches or biowaivers) may help advance generic drug development and facilitate the ANDA assessment and approval processes. FDA has opened the docket to solicit feedback from interested parties on the use of a Type V DMF for MMF submissions to support ANDAs.
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Today, the FDA announced it would no longer allow for the use of FD&C Red No. 3 in food and ingested drugs as a matter of law, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act). https://lnkd.in/e7Y3VFPM
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📣 Join SBIA January 29 for Knowledge Management and Modernization of Regulatory Quality Assessment and Submissions at FDA FDA’s Knowledge-aided Assessment and Structured Application (KASA) initiative is a creative regulatory approach for modernizing quality assessment and enhancing submission format. In this conference, FDA experts will describe KASA and its benefits, the relationship between knowledge-aided assessment and structured application, and more. Register today! ➡️ https://lnkd.in/eSP8vGhU
Join us to learn from FDA experts and earn 6.0 CME/CPE/CNE!
fda.gov
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🔔 Next week! Join SBIA January 22 for BsUFA III Regulatory Science Pilot Program: Progress Update webinar The agenda includes a recap of the activities of regulatory science pilot program from the last engagement that occurred on October 16, 2023. The webinar will include a status update on the programs current research portfolio as it relates to the BsUFA III commitments as well as presentations and panel discussions by FDA staff. There's still time to register! ➡️ https://lnkd.in/euKDyYMj
Join us for interactive Q&A panel discussion with FDA staff over BsUFA III next steps, ongoing projects.
fda.gov
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📣 There's still time to answer! Take the poll to test your knowledge in anticipation for February 11 SBIA | Joint US FDA – Health Canada ICH Public Meeting 2025 Have you registered yet? ➡️ https://lnkd.in/eCtbSuBC
📝 Test your knowledge in anticipation of our February 11 SBIA | Joint US FDA – Health Canada ICH Public Meeting 2025 webinar by responding to the question below. The answer will be posted once the poll closes. 🔔 Be sure to register! https://lnkd.in/eCtbSuBC
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Thank you to those who attended the “Optimizing the Use of Real-World Evidence in Regulatory Decision-Making for Drugs and Biological Products—Looking Forward” public workshop on December 12, 2024! To help facilitate the future direction of the RWE Program, FDA seeks input on the following questions by MONDAY. Click here to comment on this docket by 11:59 PM EST January 13, 2025 ➡️ https://lnkd.in/eK6yqKiw 1. What are critical issues that need to be addressed to further advance the use of RWE in regulatory decision-making for drugs and biological products? 2. What research priorities, including emerging technologies and AI, should CDER consider supporting? 3. FDA has published RWD/RWE guidance documents focused on data considerations, study design, and regulatory considerations. What additional topics could be prioritized for consideration? 4. What are optimal communication and engagement strategies to interact with the external community regarding RWE?
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CDER Small Business and Industry Assistance (SBIA) reposted this
Just out! The 2024 New Drug Therapy Approvals report – it includes approvals for therapies that collectively treat a wide range of conditions, including a first-in-class drug for schizophrenia, three novel antibiotics and new drugs for many types of cancer. https://lnkd.in/eVUZCxPi #FDAVoices
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