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Federal Register

Comments Sought on Biologic Manufacturing Arrangements

Federal Register notice: FDA seeks comments on an information collection extension for its Guidance for Industry: Cooperative Manufacturing Arrangemen...

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FDA releases for comment a draft guidance on CMC Post-approval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Repo...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

Nature Editorial Urges Academic Scientists to Help FDA

A Nature editorial says FDA needs help from academic scientists to review and approve new drug therapies because in-house talent is weak.

Medical Devices

FDA Clears Mauna Kea Confocal Miniprobes

FDA clears a Mauna Kea Technologies 510(k) for its CelioFlex UHD Confocal Miniprobes for use with the companys Cellvizio laser endomicroscopy platform...