FDA Related News

Medical Devices

Biliary Stent 510(k) Submission Guidance

FDA issues a draft guidance on 510(k) submissions for metal expandable biliary stents.

Commenters Seek Changes in Product Jurisdiction Rule

Three stakeholders raise concerns and suggest improvements to an FDA proposed rule on product jurisdiction.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include Baxter (Claris Injectables Ltd.) and bB BioChem Laboratories.

Medical Devices

FDA Clears Quidels Solana Bordetella Assay

FDA clears a Quidel Corp. 510(k) for the Solana Bordetella Complete Assay, a molecular diagnostic assay to be used with the Solana molecular diagnosti...

Federal Register

Info Collection for Animal Drug Investigational Use

Federal Register notice: FDA files for OMB clearance an information collection extension for New Animal Drugs for Investigational Use.

Federal Register

Draft Guide on Hypertension Drug Development

Federal Register notice: FDA makes available a draft guidance entitled Hypertension: Conducting Studies of Drugs Treat Patients on a Background of Mul...

Federal Register

OMB Approval Sought for Supplement Testing Info Collection

Federal Register notice: FDA files for OMB clearance an information collection extension for Petition To Request an Exemption From 100% Identity Testi...

Federal Register

Scientific Conference on Opioid and Nicotine Use

Federal Register notice: FDA announces a 9/27-28 Scientific Conference: Opioid and Nicotine Use, Dependence, and Recovery Influences of Sex and Gende...

Federal Register

OMB Approval Sought for Radiopharmaceuticals Info Collection

Federal Register notice: FDA files for OMB clearance an information collection entitled Guidance for Industry on Compounding and Repackaging of Radiop...

FDA Extends Review of Invokana Supplemental NDA

FDA extends by three months the review of a Janssen Pharmaceutical Companies supplemental NDA for Invokana (canagliflozin), indicated for reducing the...