FDA Related News

Antimicrobial Sales, Distribution Up Slightly

FDA says that sales and distribution of antimicrobials increased 1% from 2014 to 2015, the lowest annual increase since 2009.

Human Drugs

Trump Wild Card in Drug Price Debate: Attorney

Attorney Al Cocozza predicts that drug companies will seek to hold down drug price increases to try to avoid antagonizing President Donald Trump.

Medical Devices

FDA OKs Breast Reconstruction Tissue Expander

FDA allows marketing of AirXpanders AeroForm controllable air-filled breast tissue expander.

Human Drugs

FDA Approves Rubraca for Some Ovarian Cancers

FDA approves Clovis Oncologys Rubraca and a FoundationFocus companion diagnostic test for treating some ovarian cancer patients.

Medical Devices

FDA Bans Powdered Gloves

Stinson Leonard attorneys report that FDA has banned powdered surgeon gloves and patient examination gloves, only the second time the agency banned a ...

Medical Devices

FDA Clears Cepheid MRSA Test

FDA clears Cepheids Xpert MRSA NxG test for MRSA infection.

Human Drugs

Senators Ask Trump for Drug Price Help

Eighteen senators call on president-elect Trump to take steps to reduce prescription drug prices and pledge to work with him to accomplish that goal.

FDA General

FDA Needs to Revamp Advisory Committees: Opinion

FDA needs to revamp its advisory committee process because the agency often stacks the deck with experts that will vote to support its review findings...

Marketing

FDA to Research Deceptive Ad Identification

FDA asks for comments on proposed research to evaluate how well consumers and healthcare professionals can identify and respond to deceptive prescript...

Human Drugs

FDA Approves Spinraza for Spinal Muscular Atrophy

FDA approves Biogens Spinraza, the first drug approved for treating spinal muscular atrophy in children and adults.