June 29, 2021

JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health – 612754 – 05/26/2021

Delivery Method: United Parcel Service Product: DrugsFood & Beverages Recipient: Recipient Name Jeffrey Neil Burgee Recipient Title CEO JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health […]
June 28, 2021

FDA Drug Safety Communication: Children born to mothers who took Valproate products while pregnant may have impaired cognitive development

Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData SummaryReferences   Safety Announcement [6-30-2011] The U.S. Food and Drug Administration (FDA) is informing the public that […]
June 25, 2021

Las terapias más antiguas no son necesariamente mejores para el reemplazo de la hormona tiroidea

Image English Millones de personas tienen glándulas tiroideas que no producen suficiente hormona tiroidea para satisfacer las necesidades de su cuerpo. El hipotiroidismo, también llamado tiroides […]
June 25, 2021

Safe Use of Benzodiazepines: Clinical, Regulatory, and Public Health Perspectives – 07/12/2021 – 07/13/2021

On This Page Attend the workshop  Registration through Duke Margolis  Register In September 2020, the U.S. Food and Drug Administration announced a requirement that the Boxed […]
June 25, 2021

Sản phẩm của Vy & Tea chứa thành phần thuốc gây nguy cơ tiềm ẩn

English Version [2-26-2021] Cục Quản Lý Thực Phẩm và Dược Phẩm (FDA) khuyến cáo người tiêu dùng không nên mua hoặc sử dụng sản phẩm Vy […]
June 25, 2021

Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies

Submit Comments by 09/24/2021 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
June 24, 2021

Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings

Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance provides recommendations to […]
June 24, 2021

FDA and Center for Research on Complex Generics Co-Hosted Workshop: In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT) Methods: Best Practices and Scientific Considerations for ANDA Submissions – 08/18/2021 – 08/20/2021

On This Page Date: August 18 – 20, 2021 Day1: Wed, Aug 18 8:30 AM – 5:00 PM ET Day2: Thu, Aug 19 8:30 AM – […]
June 23, 2021

Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments – 06/28/2021 – 06/28/2021

On This Page Date: June 28, 2021 Time: 2:00 PM – 4:00 PM ET Description The Food and Drug Administration (FDA or the Agency) is announcing […]
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