FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
Human Drugs

Raniers Rx Laboratory Recalls Sterile Compounded Drugs

Raniers Rx Laboratory recalls all sterile compounded drug products within expiry to the hospital or consumer level due to concerns that practices at t...

Federal Register

List of Information Collections Approved by OMB

Federal Register notice: FDA publishes a list of information collections that have been approved by OMB under the Paperwork Reduction Act.

Federal Register

Polyethylene Glycol 3350 Approval Withdrawals Stayed

Federal Register notice: FDA extends until 11/2 the effective date of its order withdrawing approval of ANDAs for the prescription polyethylene glycol...

Human Drugs

FDA Approves Progenics Azedra for Adrenal Tumors

FDA approves Progenics Pharmaceuticals Azedra for treating some rare adrenal tumors that require systemic anticancer therapy.

Medical Devices

Sekisui Diagnostics Sekure HbA1c Assay Cleared

FDA clears a Sekisui Diagnostics 510(k) for the Sekure HbA1c assay and its use as an aid in diagnosing diabetes mellitus.

Biologics

Draft Babesiosis Risk Reduction Guidance

FDA issues a draft guidance with recommendations to reduce the risk of transfusion-transmitted babesiosis.

Human Drugs

Schakowsky Introduces Drug Pricing Bills

Rep. Jan Schakowsky (D-IL) introduces four bills intended to lower drug prices.

Human Drugs

Nektar NDA for Pain Drug Accepted for Review

FDA accepts for review a Nektar Therapeutics NDA for NKTR-181 for treating chronic low back pain in adult patients new to opioid therapy.

Federal Register

31 ANDA Approvals Being Withdrawn

Federal Register notice: FDA withdraws approval of 31 ANDAs from multiple applicants.

Federal Register

CDRH 2019 Experiential Learning Program

Federal Register notice: CDRH announces its 2019 Experiential Learning Program.