FDA Related News

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 5/17/2019.

Medical Devices

Warning on Unapproved Diabetes Management Devices

FDA issues a safety alert warning patients and health care professionals about risks associated with using unapproved or unauthorized devices for diab...

Federal Register

Info Collection Extension for Drug Patent Listings

Federal Register notice: FDA seeks comments on an information collection extension for Applications for Food and Drug Administration Approval to Marke...

Medical Devices

Flat Medical EpiFaith Epidural Syringe Cleared

FDA clears a Flat Medical 510(k) for its EpiFaith syringe to deliver safe epidural locating solution.

Federal Register

Fed Reg Correction on Device Accessories

Federal Register notice: FDA corrects a 4/12 Federal Register notice on the classification of medical device accessories distinct from other devices, ...

Human Drugs

AbbVie Halts Disappointing Brain Cancer Study

AbbVie halts a Phase 3 study called INTELLANCE-1 that was evaluating depatuxizumab mafodotin in patients with newly diagnosed glioblastoma based on da...

Human Drugs

FDA Inspected 739 (26%) of Non-U.S. Drug Sites

FDA says it inspected 26% (739) of the 2,852 foreign-based human drug manufacturing sites outside of the U.S. in fiscal year 2018.

Human Drugs

Takeda Gains Expanded Approval for Gattex

FDA approves a Takeda Pharmaceuticals supplemental NDA to expand Gattexs (teduglutide) for injection to pediatric patients aged one year and older wit...

Medical Devices

Carefusion Paying $3.3 Million For Fraud Charges

The Justice Department says Carefusion is paying $3.3 million to resolve False Claims Act charges that it bought and sold uncleared and unapproved med...

Advancing Use of Patient-Reported Outcomes

Researchers suggest priorities needed to increase the use of patient-reported outcomes as data in real-world evidence.