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Drug Delivery & Pharmaceutics
Prototype collection covering formulation science, drug delivery systems, nanomedicine, biologics delivery, manufacturing innovation, regulatory science, and AJPPS research.
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Latest Pharmaceutical Sciences Intelligence
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FDA & Regulatory Updates
- Greenwich Rx Issues Voluntary Nationwide Recall of Compounded Glutathione Due to Elevated Endotoxin Levels
by FDA on 10/06/2026 at 10:58 pmIMMEDIATE RELEASE - Tomball, Texas – October 1, 2026 – Greenwich Rx, a 503A compounding pharmacy, is voluntarily recalling specific lots of its compounded glutathione to the consumer level. The product is being recalled due to potential elevated endotoxin levels.
- Competitive Generic Therapy Approvalsby FDA on 10/06/2026 at 7:03 pm
Explore the FDA’s Competitive Generic Therapy Approvals page, offering insights into the program designed to encourage generic drug competition. Access information about approved CGT products and find resources, including a downloadable CGT approvals spreadsheet.
- Public Meeting on the Reauthorization of Generic Drug User Fee Amendments (GDUFA) - 09/17/2026by FDA on 10/06/2026 at 5:04 pm
The hybrid public meeting will be held on September 17, 2026, from 9 a.m. to 2 p.m. ET
- Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Actby FDA on 10/06/2026 at 3:05 pm
Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments required under PREA by the final due date, have failed to seek or obtain a deferral or deferral extension.
- Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – presentby FDA on 10/06/2026 at 1:53 pm
The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.
Drug Delivery Innovation
Future automated coverage of controlled release, nanotechnology, biologics, manufacturing, and formulation science.
Educational Resources
Future NAPPSA CE, webinars, AJPPS collections, and conference content.
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