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Human Drugs

Trump Plan Wants Pricing Disclosed in DTC Ads

President Trumps blueprint for lowering prescription drug prices orders FDA to require drug companies advertising their drugs to include pricing infor...

Human Drugs

Novartis Expanded Approval for MS Drug in Children

FDA expands approval of Novartis Gilenya (fingolimod) to treat relapsing multiple sclerosis in children and adolescents.

Medical Devices

Vyaire Medical Recalls AirLife Resuscitation Devices

Vyaire Medical recalls its AirLife resuscitation devices and Broselow convenience kits due to risk of a malfunction caused by an error in the products...

Medical Devices

Patient and Industry Groups Seek Diagnostics Reforms

A group of patient and industry organizations write Congressional leaders urging them to enact legislation to modernize the statutory oversight of cli...

Federal Register

Comments Sought on Biologic Samples Requests

Federal Register notice: FDA seeks comments on an information collection extension for Request for Samples and Protocols (OMB Control Number 09100206)...

Federal Register

FDA Determines ANDA Eligibility for Sodium Iodide

Federal Register notice: FDA determines that GE Healthcares sodium iodide I 123 oral solution, 2 millicuries/milliliter was not withdrawn from sale du...

Human Drugs

Draft Guide on Pediatric HIV Drug Development

FDA posts a draft guide on Pediatric HIV Infection: Drug Development for Treatment that provides general recommendations on developing drug products f...

Human Drugs

Guidance Defining Outsourcing Facility

FDA issues a guidance answering questions about how it defines a drug outsourcing facility.

Human Drugs

FDA, Oncolytics Agree on Reolysin SPA

FDA and Oncolytics Biotech agree on a special protocol assessment for a Phase 3 trial of the companys Reolysin to treat metastatic breast cancer.

Human Drugs

Injunctions Sought Against 2 Violative Stem Cell Clinics

FDA files two federal court complaints seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA appro...