Exporting Investigational New Drugs
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 1, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Export Requirements for Unapproved Drugs
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 1, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Human Drug Export Resources for Foreign Governments
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 1, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Providing Regulatory Submissions in Electronic Format: IND Safety Reports Guidance for Industry
Electronic Submissions (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 1, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

A Prescription Checklist for Older Adults in ED A Prescription Checklist for Older Adults in ED
Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - April 1, 2024 Category: Drugs & Pharmacology Tags: Emergency Medicine Source Type: news

Chemistry and pharmacology of delta-8-tetrahydrocannabinol - Abdel-Kader MS, Radwan MM, Metwaly AM, Eissa IH, Hazekamp A, ElSohly MA.
Cannabis sativa is one of the oldest plants utilized by humans for both economic and medical purposes. Although the use of cannabis started millennia ago in the Eastern hemisphere, its use has moved and flourished in the Western nations in more recent cent... (Source: SafetyLit)
Source: SafetyLit - March 30, 2024 Category: International Medicine & Public Health Tags: Alcohol and Other Drugs Source Type: news

FDA Roundup: March 29, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 29, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Pessary or Progesterone for Preterm Birth? Advantage Med Pessary or Progesterone for Preterm Birth? Advantage Med
Outcomes were similar with each intervention overall, but the medication appeared to produce better outcomes in women with a cervical length of 25 mm or less.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - March 29, 2024 Category: Drugs & Pharmacology Tags: Ob/Gyn & Women ' s Health Source Type: news

Clinical Pharmacology Guidances Advancing Drug Development and Regulatory Assessment | Role and Opportunities - 05/08/2024
Clinical Pharmacology Guidances Advancing Drug Development and Regulatory Assessment Role and Opportunities (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 29, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Conceptos b ásicos sobre biosimilares para pacientes
Los biosimilares son medicamentos seguros y eficaces para el tratamiento de muchas enfermedades como la artritis y el c áncer. Obtenga información sobre los biosimilares y cómo benefician a los pacientes. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 29, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Biosimilars Basics for Patients
Biosimilars are safe and effective medications for treating many illnesses such as arthritis and cancer. Learn about biosimilars and how they benefit patients. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 29, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Expands Indication for Gilead's Vemlidy (tenofovir alafenamide) to Treat Chronic HBV Infection in Pediatric Patients as Young as Six
March 28, 2024 -- FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy® (tenofovir... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 28, 2024 Category: Drugs & Pharmacology Source Type: news

Milestone Pharmaceuticals Announces Resubmission of New Drug Application for Etripamil for Treatment in Paroxysmal Supraventricular Tachycardia
MONTREAL and CHARLOTTE, N.C., March 28, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 28, 2024 Category: Drugs & Pharmacology Source Type: news

Aldeyra Therapeutics Announces Clinical Development Plan for Resubmission of New Drug Application for Reproxalap in Dry Eye Disease
LEXINGTON, Mass.--(BUSINESS WIRE)--Mar. 28, 2024-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 28, 2024 Category: Drugs & Pharmacology Source Type: news

Drug Trials Snapshots: LITFULO
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 28, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news