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Human Drugs

Safety Surveillance Best Practices Draft

FDA posts for comment a draft document with best practices for agency staff in conducting postmarket safety surveillance of drugs and biologics.

FDA General

Senate Sets 11/20 FDA Confirmation Hearing

The Senate Health, Education, Labor & Pensions Committee schedules an 11/20 confirmation hearing for FDA commissioner nominee Stephen Hahn.

Human Drugs

Sandoz Neulasta Biosimilar Approved

FDA approves Sandozs Ziextenzo (pegfilgrastim-bmez), a biosimilar to Amgens Neulasta (pegfilgrastim).

Medical Devices

Expanded Field-of-View Laparoscope Cleared

FDA clears a 270Surgical Ltd. 510(k) for its SurroundScope System, which the company describes as the first laparoscopic camera system to offer up to ...

Human Drugs

Put Tramadol in High CSA Classification: Public Citizen

Public Citizen petitions FDA and the Drug Enforcement Administration to up-classify Tramadol and similar drugs from Schedule 4 to Schedule 2 under the...

Human Drugs

CBER Regulatory Meeting SOPP

CBER issues a SOPP on regulatory meetings under some user fee programs.

Human Drugs

GSK Asks FDA Review of Zofran Information

GlaxoSmithKline asks FDA to look at four categories of information that have been raised in litigation over Zofran pregnancy labeling and determine wh...

Medical Devices

Vyaire Medical Gains Ventilator Clearance

FDA clears a Vyaire Medical 510(k) for the bellavista 1000e ventilator.

Biologics

Cell/Tissue Product eSubmission Instructions

CBER posts Instructions for Using the Electronic Human Cell and Tissue Establishment Registration System (eHCTERS).

Federal Register

8 FDA Info Collections Gain OMB Approval

Federal Register notice: FDA posts a list of eight information collections that have been approved by OMB.