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- FDA] FDA Issues Emergency Use Authorization for Generic Over-the-Counter Drug to Treat New Wor For Immediate Release June 11, 2026 The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for generic Nitenpyram Tablets (nite
- [Philippines FDA] FDA Advisory No.2026-0608 || Public Health Warning Against the Purchase and Use of FDA Advisory No.2026-0608 || Public Health Warning Against the Purchase and Use of the Counterfeit Drug Freeze-Dried Powder for Injection (IM/ID)” Updated: 2026-06-02 The Food and Drug Administration (FDA)
- [Philippines FDA] FDA Advisory No.2026-0601 || Public Health Warning Against the Purchase and Use of FDA Advisory No.2026-0601 || Public Health Warning Against the Purchase and Use of the Counterfeit Drug Freeze-Dried Powder for Injection (IM/ID)” Updated: 2026-05-28 The Food and Drug Administration (FDA)
- [Philippines FDA] FDA Advisory No.2026-0599 || Public Health Warning Against the Purchase and Use of FDA Advisory No.2026-0599 || Public Health Warning Against the Purchase and Use of the Counterfeit Drug ) advises the public against the purchase and use of the counterfeit version of the following product
- FDA] FDA Advisory No.2026-0612 || Public Health Warning Against the Purchase and Use of the Co FDA Advisory No.2026-0612 || Public Health Warning Against the Purchase and Use of the Counterfeit Drug use of the counterfeit version of the following product: 1.
- [U.S. FDA] FDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food The FDA is issuing a final order revoking the authorized use of Orange B as a color additive in food and is proposing to revoke the authorized use of Citrus Red No. 2 as a color additive in food.
- GCCL(지씨씨엘) 웨비나 후기 - [바이오마커 2편] 바이오마커 Claim은 어떻게 인정되는가? 이번 웨비나는 R&D Unit 인경민 유닛장이 연자로 참여하여 바이오마커를 활용한 신약개발 과정에서 자주 접하게 되는 규제적 이슈와 실제 FDA 허가 사례를 중심으로 실무적인 바이오마커의 Context of Use(COU) 개념을 중심으로, Response Biomarker와 PD Biomarker의 차이 Surrog.......
- [Philippines FDA] FDA Advisory No.2026-0708 || INFORMATION ON BLEACH POISONING PREVENTION FDA Advisory No.2026-0708 || INFORMATION ON BLEACH POISONING PREVENTION Updated: 2026-07-01 Proclamation It is use.......
- [U.S. FDA] FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients Food and Drug Administration (FDA) today issued draft guidance to help developers bring promising gene and clinical information, to streamline regulatory submissions for human gene therapy products that use
- [U.S. FDA] FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose Food and Drug Administration (FDA) today approved another over-the-counter (OTC) intranasal naloxone s Great American Recovery Initiative, a federal effort to address the U.S.’ addiction and substance use