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Federal Register

Device User Fee Meeting Postponed

Federal Register notice: FDA postpones until further notice a 5/5-scheduled public meeting entitled Medical Device User Fee Amendments for Fiscal Year...

Medical Devices

EUA Templates to Speed Serology Tests: FDA

FDA says it is working on emergency use authorization templates that laboratories and commercial manufacturers may use to facilitate the preparation a...

Human Drugs

Avet Pharma Recalls Tetracycline HCl Capsules

Avet Pharmaceuticals recalls several lots of tetracycline HCl capsules, 250 mg and 500 mg, 100-count bottles due to low out-of-specification dissoluti...

Human Drugs

Nova Botanix Warning on Unapproved Virus Products

FDA warns Nova Botanix that its CBD products are being marketed for unapproved drug uses in treating or preventing Covid-19.

Human Drugs

FDA Approves Pemazyre for Cholangiocarcinoma

FDA approves an Incyte Corp. NDA for Pemazyre (pemigatinib) for treating adults with certain types of previously treated, advanced cholangiocarcinoma,...

Human Drugs

Fresenius Kabi Recalls Ketorolac Tromethamine

Fresenius Kabi recalls 13 lots of ketorolac tromethamine injection, 30 mg/ml, and ketorolac tromethamine injection 60 mg/2 ml due to the presence of p...

FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

Human Drugs

International Labs Recalls Mislabeled Clopidogrel

International Laboratories recalls one lot of clopidogrel tablets due to a mislabeling.

Human Drugs

CDER Revises ANDA Review Internal Policy

CDER revises a Manual of Policies and Procedures entitled ANDA Amendments and Supplements Reviewed by the Division of Filing Review.

Human Drugs

New Content Added to Clinical Trials Guide

FDA adds new content to a question-and-answer appendix for its guidance on Conduct of Clinical Trials of Medical Products during Covid-19 Public Healt...