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Federal Register

Comments Sought on Drug Ad Information Requirements

Federal Register notice: FDA seeks comments on an information collection for Prescription Drug Advertisements.

Human Drugs

Draft Guide on Biologic CMC Post-Approval Changes

FDA releases for comment a draft guidance on CMC Post-approval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Repo...

Human Drugs

Comments Sought on ICH Safety Reporting Waivers

Federal Register notice: FDA seeks comments on an information collection for Providing Waiver-Related Materials in Accordance With the Guidance for In...

Human Drugs

NCI Study Finds Cancer Immunotherapy Genes

A National Cancer Institute study identifies genes that may play a role in facilitating tumor destruction.

Human Drugs

Pew Launching Antibiotic Info-Sharing Platform

The Pew Charitable Trusts says it will launch an information-sharing digital platform in hopes of spurring discovery of innovative new antibiotics.

Medical Devices

Siemens Addressing Windows 7 Imaging Vulnerabilities

Siemens says it will update four medical molecular imaging products running on Windows 7 that have vulnerabilities that could be exploited remotely.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Cellex-C International and Skin Sciences Laboratory.

Human Drugs

GMP Inspection Causes FDA Denial of Valeant Eye Drug

FDA issues Valeant Pharmaceuticals a complete response letter on its NDA for latanoprostene bunod ophthalmic solution, 0.024%, an investigative intrao...

Medical Devices

GEs Signa Premier MRI for Brain Injury Detection Cleared

FDA clears a GE Healthcare 510(k) for the Signa Premier, a new wide bore 3.0T magnetic resonance imaging system.

Human Drugs

New DTC Research Examines New Risk Presentation Model

New research by FDA and RTI Internationals Center for Communication Science shows promising data on a new model for presenting risk information in bro...