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Tablets & Capsules October 2020 7 FDA clears COVID-19 oral vaccine Phase 1 clinical trial SAN FRANCISCO, CA—The FDA reviewed and approved the inves- tigational new drug (IND) application for a Phase 1 clinical trial of Vaxart's oral tablet COVID-19 vaccine. The agency's clearance allows the bio- technology manufacturer to conduct a Phase 1 clinical study on healthy adults aged 18 to 55 to examine the safety of two doses of the vaccine. FDA publishes 19 new and 17 revised PSGs SILVER SPRING, MD—The FDA published 36 product-specific guid- ances (PSGs), providing recommen- dations for developing generic drugs and generating evidence for Abbrevi- ated New Drug Application approval. Of the latest batch of PSGs, 19 were new guidances and 17 were revisions to previously published guidances. The full list of PSGs can be found at www.accessdata.fda.gov/scripts/cder/ psg/index.cfm. ISPE publishes cleaning validation lifecycle guide NORTH BETHESDA, MD—The International Society for Pharma- ceutical Engineering (ISPE) has pub- lished "ISPE Guide: Cleaning Valida- tion Lifecycle - Applications, Meth- ods, and Controls," a guide written by experts and reviewed by regulators and practitioners with comprehensive explanations and recommendations for the cleaning validation lifecycle. The document addresses the applica- tion of risk management, adoption of a lifecycle approach for cleaning val- idation, cleaning methodologies, cre- ation of cleaning validation accep- tance criteria, determination of visual inspection limits, calculation and jus- tification of residue limits, validation of testing and sampling methods, equipment issues and challenges, and change management. FDA publishes EoE drug development final guidance SILVER SPRING, MD—The FDA finalized a guidance for industry on developing drugs to treat eosinophilic esophagitis (EoE), a chronic immune disease in which inflammation causes the esophagus to narrow, making it difficult to swallow food. There is cur- rently no FDA-approved treatment for EoE. The guidance provides the agen- cy's current thinking regarding clinical trials and development programs for EoE drugs as well as recommendations for patient enrollment, trial designs, efficacy considerations, safety assess- ments, and pediatric considerations. FDA approves acute myeloid leukemia treatment SUMMIT, NJ—The FDA approved Onureg (azacytidine) tablets to treat patients with acute myeloid leukemia who achieved first complete remission or complete remission with incom- plete blood count recovery after intensive induction chemotherapy and are not able to complete intensive curative therapy. The product is man- ufactured by Celgene. PNEUMATIC CONVEYING COMPONENTS & SYSTEMS • FEEDER REFILL SYSTEMS BULK BAG LOADING & UNLOADING SYSTEMS • PACKAGING MACHINE REFILL SYSTEMS MOBILE CONVEYING SYSTEMS • BATCH WEIGHING & SCALING SYSTEMS • CONTROLS 69 William Street • Belleville, NJ 07109 • (800) VAC-U-MAX • info@vac-u-max.com Vacuum convey from handfuls to 3500 lbs/hr of free-flowing and non-free flowing powders and granular materials. Automating Processes. Guaranteed. Let us solve your powder and bulk material handling needs, challenges, and requirements for compliance. Fill out RFQ at www.vac-u-max.com or call (800) VAC-U-MAX. Signature Series TM vacuum receivers for continuous, gentle, dust-free, and hygienic material transfer. Refill Pharmaceutical Feeders Refill Packaging Machines Refill Tablet Presses Refill Blenders/Mixers and more! TabletsCapsules-Product 4.5625 x 7.5 PC PHARMA-FALL2020.indd 1 9/10/2020 2:15:00 PM