FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
Human Drugs

Study Backs Ketamine as Antidepressant

Researchers say a large-scale population study confirms anecdotal reports of ketamines effectiveness as an antidepressant.

FDA General

Comey Firing Causes Postponement of FDA User Fee Mark-up

Responding to the firing of FBI director James Comey, the Senate Health, Education, Labor, and Pensions Committee postpones a planned mark-up of a bil...

Federal Register

Comments Sought on Revisions to FDA Blueprint for Opioid Prescribers

Federal Register notice: FDA announces the availability of draft revisions to the FDA Blueprint for Prescriber Education for Extended-Release and Long...

Human Drugs

Cancer Drugs Approved Fastest in U.S.: FOCR

Friends of Cancer Research releases updated statistics showing that FDA reviews and approves cancer drugs faster than the European Medicines Agency.

Human Drugs

Fluoroquinolone Antibiotic Issues Not Supported: FDA

FDA says reports that fluoroquinolones may result in retinal detachment, aortic aneurysm or aortic dissection are not supported by patient cases ident...

Human Drugs

Inspection Finds CGMP Deviations at Huron Pharmaceuticals

FDAs Detroit District Office warns Huron Pharmaceuticals about CGMP deviations in the production of active pharmaceutical ingredients.

Human Drugs

FDA Accelerated Approval for EMD Seronos Bavencio

FDA grants accelerated approval to an EMD Serono NDA for Bavencio (avelumab) for certain patients with locally advanced or metastatic urothelial carci...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Huron Pharmaceuticals, Lonza Group, Rainbow Gold Products, and Vikshara Trading & Inves...

Human Drugs

FDA Helping Drug Makers on Continuous Manufacturing

CDERs Sau Lee says FDA is taking steps to facility drug manufacturer use of emerging technologies such as continuous manufacturing.

FDA General

HELP Committee Releases Update User Fee Draft for Mark-up

The Senate Health, Education, Labor, and Pensions Committee releases a Managers Amendment to S. 934 FDA Reauthorization Act of 2017 that would reautho...