CDER Small Business and Industry Assistance (SBIA)

📣 Register today! 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

FDA published two case studies and a case study user guide developed as part of the Accelerating Rare disease Cures (ARC) Program’s Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D) initiative. The ARC Program launched LEADER 3D to better understand and address the unique challenges in bringing rare disease products to market. These case studies highlight approaches successfully used by sponsors when designing and conducting rare disease drug development programs. The materials on the LEADER 3D website are reflective of the needs and priorities heard from our valuable partners in the rare disease drug development community. Learn more and read the case studies: https://lnkd.in/eEW-xreB

📣 TODAY! Join SBIA for Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions webinar This event will provide an update on FDA’s efforts related to model master files (MMFs). The agenda includes presentations by FDA staff that will focus on an introduction and overview of MMFs, considerations for developing and submitting MMFs to support ANDAs using a Type V DMF, and a cross-comparison to other types of DMFs, including lessons learned. There's still time to register! ➡️ https://lnkd.in/eD8AzpnY

🔔 Tomorrow! Join SBIA for Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions webinar This event will provide an update on FDA’s efforts related to model master files (MMFs). The agenda includes presentations by FDA staff that will focus on an introduction and overview of MMFs, considerations for developing and submitting MMFs to support ANDAs using a Type V DMF, and a cross-comparison to other types of DMFs, including lessons learned. Will you join us? ➡️ https://lnkd.in/eD8AzpnY

📣 March 13! Join SBIA for Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions webinar This event will provide an update on FDA’s efforts related to model master files (MMFs). The agenda includes presentations by FDA staff that will focus on an introduction and overview of MMFs, considerations for developing and submitting MMFs to support ANDAs using a Type V DMF, and a cross-comparison to other types of DMFs, including lessons learned. There's still time to register! ➡️ https://lnkd.in/eD8AzpnY

📣 Join SBIA March 13 for Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions webinar This event will provide an update on FDA’s efforts related to model master files (MMFs). The agenda includes presentations by FDA staff that will focus on an introduction and overview of MMFs, considerations for developing and submitting MMFs to support ANDAs using a Type V DMF, and a cross-comparison to other types of DMFs, including lessons learned. Register today! ➡️ https://lnkd.in/eD8AzpnY

📣 TODAY! Join SBIA for the Navigating Controlled Correspondences to Support Generic Drug Development webinar This event offers a comprehensive overview of controlled correspondence as an efficient pathway for communication with the FDA regarding generic drug development. FDA will host a panel discussion on topics pertinent to the generic drug industry, and answer questions during live Q&A sessions with FDA experts. ❗There's still time to register ➡️ https://lnkd.in/eSMgP69p

FDA approved Ctexli (chenodiol) for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. Ctexli is the first FDA-approved drug to treat CTX, a very rare lipid storage disease. CTX is a genetic metabolic disorder caused by a mutation in a gene called CYP27A1 resulting in a deficiency of the enzyme sterol 27-hydroxylase that is important in the body’s ability to break down fats. Patients with CTX have reduced bile acid production and accumulation of cholesterol metabolites, including cholestanol, in various tissues such as the brain, liver, skin, and tendons. These deposits can lead to progressive damage. Ctexli works to replace deficient levels of the endogenous bile acid, chenodeoxycholic acid, in patients with CTX and reduce cholesterol metabolites thought to be responsible for CTX manifestations and progression. The prescribing information for Ctexli includes a warning for liver toxicity in all patients with increased risk for liver damage in patients with pre-existing liver disease or bile duct abnormalities. Patients should obtain liver tests before starting treatment, annually while on treatment, and as clinically indicated. If signs of liver toxicity occur patients are advised to see their doctor and discontinue Ctexli. The recommended dosage is 250 mg, taken orally three times a day. The most common side effects of Ctexli are diarrhea, headache, abdominal pain, constipation hypertension, muscular weakness, and upper respiratory tract infection. Learn more in the FDA-approved prescribing information below and at: https://lnkd.in/esUf7HMi

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.

📣 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