FDA Related News

Marketing

FDA Wants Comments on Proposed DTC Study

FDA asks for comments on proposed research looking at how consumers respond to disease awareness communications that accompany television direct-to-co...

Marketing

DTC Ad Efficacy and Risk Info Guidance

FDA issues a draft guidance with recommendations for how companies can present quantitative efficacy and risk information in DTC human and animal drug...

Human Drugs

Pfizers Talzenna OKd for Breast Cancer

FDA approves Pfizers Talzenna (talazoparib), a poly (ADP-ribose) polymerase inhibitor for certain patients with locally advanced or metastatic breast ...

3-Factor Approach for Product Communications: FDA

FDA outlines a three-factor approach it uses to evaluate whether a drug- or device-related product communication is consistent with the products agenc...

Medical Devices

FDA Rejects TearLab 510(k) for Dry Eye Test

FDA rejects a TearLab Corp. 510(k) for its TearLab Discovery MMP-9 test for dry eye disease.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include Hanlim Pharm Co. and Ignatius P. Godoy.

Human Drugs

CGMP Violations at Koreas Hanlim Pharm

FDA warns South Koreas Hanlim Pharma about CGMP violations in its manufacturing of finished pharmaceuticals.

Marketing

Afrezza Facebook Post False, Misleading: OPDP

CDERs Office of Prescription Drug Promotion says a Facebook post about MannKinds Afrezza misbrands the drug by failing to adequately discuss its serio...

Federal Register

FDA Draft Guide on Rare Disease Pre-IND Meetings

Federal Register notice: FDA makes available a draft guidance entitled Rare Diseases: Early Drug Development and the Role of Pre-Investigational New D...

Medical Devices

Class 1 Recall for Endologicx Endovascular AAA Device

FDA classifies as a Class 1 recall an Endologix safety notice to healthcare professionals about its AFX Endovascular AAA [abdominal aortic aneurysm] S...