medscopeglobal.com · FDA · Novinky

Novinky k humánním lékům

Aktuální sdělení FDA k humánním léčivým přípravkům a regulaci v USA.

Beekeeper’s Naturals Issues Voluntary Nationwide Recall of Beekeeper’s Naturals Saline Nasal Spray Sold Through Amazon Due to Microbial Contamination

FDA · 15. 6. 2026

FOR IMMEDIATE RELEASE – June 11, 2026, Covina, CA - Beekeeper’s Naturals is voluntarily recalling lot # 5950, Exp. Date 02/2028 of Beekeeper’s Naturals Saline Nasal Spray, sold only through Amazon, to the consumer level.

Novinka

Frequently Asked Questions About Drugs

FDA · 15. 6. 2026

Frequently Asked Questions About Drugs<br>

Novinka

Compounding Quality Center of Excellence | Self-Guided Online Trainings

FDA · 15. 6. 2026

FDA Compounding Quality Center of Excellence’s is providing anytime, anywhere training resources to support outsourcing facilities and other stakeholders in their efforts to enhance the quality of compounded drugs.

Novinka

Human Drug Imports

FDA · 15. 6. 2026

Human drug import information including PLAIR, safe importation action plan, and personal importation policy.

Novinka

Compounding Quality Center of Excellence | Instructor-Led Trainings

FDA · 15. 6. 2026

The Compounding Quality Center of Excellence’s free in-person training programs target outsourcing facility staff and offer continuing education credits. The training will open for state regulators and pharmacy compounders if space is available.

Schváleno

Development of Antihypertensive Therapies for Use in Pediatric Patients

FDA · 15. 6. 2026

Treatment of chronic hypertension (high blood pressure) in pediatric patients remains an area of unmet medical need, with limited FDA-approved therapies, particularly for children younger than six years of age. Products are being developed to treat uncontrolled and/or resistant hypertension in adults that may have benefits in pediatric patients.

Novinka

Generic Drug User Fee Amendments

FDA · 13. 6. 2026

This page features news and information for industry and stakeholders about GDUFA, its fee structure, payment methods, and related information.

Novinka

Study Data Technical Conformance Guide

FDA · 12. 6. 2026

This technical specifications document represents the Food and Drug Administration's (FDA's) current thinking on this topic.

Schváleno

FDA Approves Drug for Pediatric Stage 3 Type I Diabetes

FDA · 12. 6. 2026

The U.S. Food and Drug Administration (FDA) has approved Tzield (teplizumab) injection to delay (slow down) the loss of the body’s own insulin production for pediatric patients aged 8 to 17 years recently diagnosed with Stage 3 Type I diabetes (T1D).

Novinka

Schválení nového léku

FDA · 12. 6. 2026

Aktualizace z oficiálního zdroje FDA. MedScopeGlobal přináší strukturovaný přehled pro českou odbornou praxi s odkazem na primární dokument.

Novinka

Oncology (Cancer)/Hematologic Malignancies Approval Notifications

FDA · 12. 6. 2026

FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products.

Pipeline

Novinky z FDA

FDA · 11. 6. 2026

Denní přehled registrací a aktualit z agentury FDA

Schváleno

Nový lék schválen FDA

FDA · Lék X · 11. 6. 2026

FDA schválila nový lék pro léčbu pacientů s vzácnou nemocí

Novinka

ClinicalTrials.gov: Essentials for Academic Medical Centers

FDA · 11. 6. 2026

This virtual training is designed to help staff at academic medical centers meet the federal requirements for registering clinical studies and reporting results on ClinicalTrials.gov.

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