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FDA Looking for Patient Engagement Collaborative Members

FDA issues a request for nominations of people with disease experience to a new Patent Engagement Collaborative.

FDA General

Recent Federal Register Postings

FDA Webview posts the summaries of the Federal Register notices published during our holiday break.

FDA General

Latest FDA Warning Letters

FDA Webview posts Warning Letters released by FDA during our Holiday break for AN Co., Amaros Co., C.O. Truxton, Fresenius Kabi AG, Fresenius Kabi Onc...

Human Drugs

FDA Approves Luxturna for Rare Vision Loss

FDA approves Spark Therapeutics Luxturna for treating patients with a form of retinal dystrophy.

Human Drugs

FDA Risk-Based Enforcement for Homeopathic Drugs

FDA says it will take a new risk-based enforcement approach to homeopathic drugs that are marketed for serious illnesses or dont have demonstrated cli...

Human Drugs

Senators Question Drug Import Enforcement

Senators Grassley and Klobuchar ask FDA if the non-enforcement policy for some drug importation from Canada has changed.

Medical Devices

FDA Clears GammaPod Breast Cancer Treatment

FDA clears Xcision Medical Systems GammaPod breast cancer radiation treatment.

Medical Devices

FDA Permits Marketing of Dermapace Foot Ulcer Device

FDA allows marketing of Sanuwaves Dermapace System to treat diabetic foot ulcers in adult patients with pulses of energy to mechanically stimulate the...

Human Drugs

CDER Approvals Double to 46 Innovative Products

CDER innovative drug approvals sharply rebound in 2017 more than doubling the 22 products approved in 2016, which was a significant down year for app...

Human Drugs

FDA Issues 2 Drug Communication Guidances

FDA releases two guidances on communications with drug sponsors.