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Medical Devices

Electronic Format Regulatory Submission Guidance

FDA publishes the first in a series of guidances with standards for medical device submissions in electronic format.

FDA General

FDA Slowness Helped e-Cig Epidemic: Rep. Pallone

House Energy and Commerce chair Frank Pallone (D-NJ) says the current youth vaping epidemic could have been averted if FDA in 2017 had not delayed rev...

Human Drugs

FDA Gives Danicopan Breakthrough Designation

FDA grants breakthrough therapy designation to Achillion Pharmaceuticals danicopan for treating paroxysmal nocturnal hemoglobinuria.

Medical Devices

Abiomeds Newest Heart Pump Approved

FDA approves Abiomeds newest heart pump, the Impella 5.5 with SmartAssist, indicated for temporary ventricular support (14 days) and for treating ongo...

Medical Devices

FDA Breakthrough Status for Concussion Device

FDA grants Aurora Concussion Therapy Systems a breakthrough device designation for its Aurora Light Therapy System for treating concussions.

Human Drugs

Florida Canadian Drug Importation Plan

Florida submits a concept paper to HHS explaining how it wants to operate a Canadian prescription drug importation program.

Biologics

Trump Said to Modernize, Improve Flu Vaccines

The White House says President Trump has signed an executive order intended to modernize flu vaccines and help protect more Americans through vaccinat...

Human Drugs

NDA to BLA List Updated

FDA updates its preliminary list of approved NDAs that will be considered BLAs as of 3/23/20.

Federal Register

Guide on Drug Distributor Verification Requirement

Federal Register notice: FDA makes available a final guidance entitled Wholesale Distributor Verification Requirement for Saleable Returned Drug Produ...

Federal Register

Comments Sought on Pediatric Drug Safety Reviews

Federal Register notice: FDA seeks comments related to post-marketing pediatric-focused safety reviews of products posted between 4/12 and 9/23 on the...