CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.
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Science-based health and safety information you can trust.FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
On July 2, 2025, the Food and Drug Administration granted accelerated approval to sunvozertinib (Zegfrovy, Dizal (Jiangsu) Pharmaceutical Co., Ltd.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertioPatient Engagement Collaborative
The Patient Engagement Collaborative (PEC) is an advancement in the FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Public Engagement Staff.www.buyprosoma.com – 705973 – 06/10/2025
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the InternetFantasy Aphrodisiac Chocolate may be harmful due to hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Fantasy Aphrodisiac Chocolate, a product promoted and sold for sexual enhancement on various websites, including gearisle.com, and possibly in some retail stores.Drug Development Tool Qualification Process: Transparency Provisions
Under the 21st Century Cures Act enacted on December 13, 2016, the new section 507 Qualification of Drug Development Tools was added to the Federal Food, Drug, and Cosmetic Act and formally establishes an updated, multi-stage process for DDT qualification. This process includes three submission mil