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Federal Register

Info Collection on Device Safety Communications

Federal Register notice: FDA sends to OMB an information collection extension on Testing Communications on Medical Devices and Radiation-Emitting Prod...

Federal Register

Info Collection on Social/Behavioral Research

Federal Register notice: FDA seeks comments on a new information collection for qualitative data to support social and behavioral research for certain...

FDA General

Trump Budget Proposes Flat $6.2 Billion FDA Budget

President Trump proposes a relatively flat (1.6% increase) $6.2 billion budget for FDAs fiscal year 2021 budget, which includes $3.3 billion for budge...

FDA General

FDA Phone Safety Review: No Adverse Health Effects

A new FDA literature review on cell phone radiofrequency radiation exposure on human health finds no quantifiable adverse health effects.

Human Drugs

Lilly Reports Miss on Alzheimers Study

Eli Lilly says it does not plan to pursue an NDA submission for solanezumab for treating patients with dominantly inherited Alzheimers disease based o...

Federal Register

Info Collection on Device Risk Allegations

Federal Register notice: FDA seeks comments on an information collection entitled Electronic Submission Process for Voluntary Allegations to the Cente...

Human Drugs

Janssen sBLA for Darzalex Combination Use for Myeloma

FDA accepts for review a Janssen Pharmaceutical supplemental BLA for Darzalex (daratumumab) for use in combination with Amgens Kyprolis (carfilzomib) ...

Federal Register

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 2/7/2020.

FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

Federal Register

Draft Guide on sBLA for Biosimilar Use

Federal Register notice: FDA announces a draft guidance entitled Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions ...