FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Human Drugs

Glass Vial, Stopper Guidance

FDA publishes a guidance with recommendations for reporting categories and the content of postapproval change submissions about glass container closur...

latest-news-card-1
Human Drugs

FDA Wants Host Cell Protein Immunogenicity Info

FDA establishes a docket for information and comments on evaluating and mitigating the immunogenicity risk of host cell proteins.

latest-news-card-1
Human Drugs

CGMP Violations at Yahon Enterprise

FDA warns Vietnams Yahon Enterprise about CGMP violations in its manufacturing of finished drugs.

latest-news-card-1
Human Drugs

Hikma Recalls Acetaminophen Lot Over Mix-up

Hikma Pharmaceuticals extends a Class 1 recall of one lot of acetaminophen injection, 1,000mg/100mL due to the potential presence of a bag labeled dex...

latest-news-card-1
Federal Register

Comment Period Extended on FDA IT Strategy

Federal Register notice: FDA extends the comment period on its 6/26-released Information Technology (IT) Strategy and Customer Experience Strategy....

latest-news-card-1
Federal Register

OMB OKs Quantitative Claims Survey for DTC Ads

Federal Register notice: FDA announces that OMB has approved an information collection entitled Survey on Quantitative Claims in Direct-to-Consumer Pr...

latest-news-card-1
Medical Devices

Input on Non-Device Software Functions

Three stakeholders provide requested input to FDA on the risks and benefits of non-device software functions.

latest-news-card-1
Human Drugs

Brassica Pharma CGMP Violations

FDA warns Indias Brassica Pharma about CGMP violations in its production of finished drugs at a facility in Thane, India.

latest-news-card-1
Medical Devices

QS Issues in Criticare Inspection

FDA warns Criticare Technologies about QS violations in its manufacturing of patient monitors at a medical device facility in Warwick, RI.

latest-news-card-1
Medical Devices

FDA Posts Laboratory-Developed Test FAQs

FDA posts answers to frequently asked questions about its new laboratory-developed test final rule.