🔔 Book Your Special Rate Room by August 23! SBIA | Advancing Generic Drug Development: Translating Science to Approval 2024 Join us for the 2024 Advancing Generic Drug Development workshop. FDA experts will discuss and analyze the complex scientific issues encountered in generic drug development and abbreviated new drug applications (ANDAs). Register today: https://lnkd.in/emXB-9VY Agm Mostofa, Thilak Mudalige, Dongkai Zhu, Hee Sun Chung Xiaoming Xu,Megan Kelchen, Eleftheria Tsakalozou Tannaz Ramezanli Hiren Patel Pahala Simamora Ross Walenga Changning Guo Elizabeth Bielski, PhD Zhen Xu William Chong Lei Zhang, Ph.D., FAAPS Tina Jiao Maria Flynn Nashwa El-Gendy Bryan Newman Yang Lu, PhD Fang Wu Likan Liang Greg Huang Priyanka Ghosh Yuqing Gong Nilufer Tampal Robert Lionberger
CDER Small Business and Industry Assistance (SBIA)
Pharmaceutical Manufacturing
Silver Spring, MD 42,065 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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The FDA collaborated with PHUSE/CDISC to execute a pilot from September 2023 thru April 2024 to test the feasibility of using CDISC Dataset-JSON as a transport format for study data submitted with regulatory applications. The pilot aimed to demonstrate that CDISC Dataset-JSON can serve as a transport file for study data without loss of data and no significant impact to business operations. The presentation will present the findings of the pilot and next steps as published in the PHUSE white paper. View the webinar here ➡ https://lnkd.in/drPp4YSg
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FDA finalizes guidance on Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products. Read Final Guidance: https://lnkd.in/eqddcAan
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CDER Small Business and Industry Assistance (SBIA) reposted this
FDA issued a Federal Register notice, “Biosimilar Product Development Guidance; Establishment of a Public Docket; Request for Information and Comments,” which establishes a public docket that seeks comments to determine whether biosimilar product development would be best served by focusing on product class-specific guidance documents that address common development issues that apply to a broad class of products, or by developing product-specific guidance documents: https://lnkd.in/grC5S8gp Submit any comments regarding this notice to the public docket (Docket No. FDA-2024-N-3228) until October 24, 2024. Visit the Federal Register notice for additional information on how to comment.
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🔔 Coming September 12! Don't miss SBIA's Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2024 Learn how to submit establishment registration and drug listing (eDRLS) data using CDER Direct. This Small Business and Industry Assistance (SBIA) webinar will feature case studies for an interactive learning experience. Register today: https://lnkd.in/e2JG95ck Ugwu-Oju, Obinna Regie Samuel Soo Jin Park Laurie Simonds Lalnunpuii Huber Troy Cu Leyla Rahjou-Esfandiary Yogesh Paruthi, BPharm, PharmD Vikas Arora David Mazyck Julian Chun Tasneem Hussain Jeffrey Trunzo
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🔔Earn 1.5 CE hours next week! SBIA | Webinar: Environmental Monitoring in Compounding Learn from the experts at this July 30 Small Business and Industry Assistance (SBIA) webinar. FDA speakers will offer an overview of the statutory and regulatory requirements for environmental monitoring as well as the agency’s expectations for compounding pharmacies (under section 503A) and outsourcing facilities (under section 503B). The discussion will also cover different methods specific to environmental monitoring. Register today! https://lnkd.in/exNZJDsZ Doan-Trang Vuong, MS Brandon C. H.
Environmental Monitoring in Compounding
fda.gov
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Attention Health care providers: Are you confused about the difference between biosimilars and interchangeable biosimilars and are curious to learn more? Check out 9 things about biosimilars and interchangeable biosimilars here: https://bit.ly/45KKIWw
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🔔 Register and Book Your Room Early! SBIA | Advancing Generic Drug Development: Translating Science to Approval 2024 Join us for the 2024 Advancing Generic Drug Development workshop. FDA experts will discuss and analyze the complex scientific issues encountered in generic drug development and abbreviated new drug applications (ANDAs). Register today: https://lnkd.in/emXB-9VY Agm Mostofa, Thilak Mudalige, Dongkai Zhu, Hee Sun Chung,Xiaoming Xu,Megan Kelchen, Eleftheria Tsakalozou Tannaz Ramezanli Hiren Patel Pahala Simamora Ross Walenga Changning Guo Elizabeth Bielski, PhD Zhen Xu William Chong Lei Zhang, Ph.D., FAAPS Tina Jiao Maria Flynn Nashwa El-Gendy Bryan Newman Yang Lu, PhD Fang Wu Likan Liang Greg Huang Priyanka Ghosh Yuqing Gong Nilufer Tampal Robert Lionberger
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FDA has issued a draft guidance for industry, “Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment,” to help sponsors in the clinical development of drugs to treat pediatric patients with inflammatory bowel disease (IBD). Read Draft Guidance: https://lnkd.in/e45GyWEj
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If your early-stage small business is new to the regulatory landscape, don’t miss this chance to learn directly from FDA experts! Get an overview of resources and programs developed across the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH) that can help academic life science accelerators and early-stage, oncology-related companies. Q&A sessions will be offered. 🔔 Register early! https://lnkd.in/ehUeuvsz
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