FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Qualigen 510(k) for FastPack IP Sex Hormone Assay

[ Price : $8.95]

Qualigen has submitted a 510(k) for its FastPack IP Sex Hormone Binding Globulin (SHBG) Immunoassay, indicated for the quantitativ...

Reviewers See Oliceridine Abuse, Overdose Potential

[ Price : $8.95]

FDA medical reviewers tell members of the Anesthetic and Analgesic Drug Products Advisory Committee that they believe Trevenas oli...

ECAN OTC Heartburn Drug Petition Denied

[ Price : $8.95]

FDA denies a petition asking for a warning about the risk of esophageal cancer on labels for OTC heartburn products.

25 New and Revised ANDA Bioequivalence Draft Guides

[ Price : $8.95]

Federal Register notice: FDA makes available two new product-specific draft guidances for submitting ANDAs for capsaicin and estra...

FDA Offers Path Forward for Twirla NDA

[ Price : $8.95]

The CDER Office of New Drugs suggests a way that Agile Therapeutics can proceed with its Twirla contraceptive patch that received ...

Eximo Laser Cleared for Peripheral Artery Disease

[ Price : $8.95]

FDA clears Eximo Medical 510(k) for the B-Laser Atherectomy System for treating peripheral artery disease.

Panel to Discuss Opioid Analgesic Sparing Outcomes

[ Price : $8.95]

Federal Register notice: FDA announces an 11/15 Anesthetic and Analgesic Drug Products Advisory Committee meeting to discuss the a...

Class 1 Recall for Endologix Safety Notice

[ Price : $8.95]

FDA classifies as a Class 1 recall an Endologix safety notice to healthcare professionals about its AFX Endovascular AAA System an...

Novartis NDA Accepted for Multiple Sclerosis Drug

[ Price : $8.95]

FDA accepts for review a Novartis NDA for once-daily siponimod (BAF312) for treating secondary progressive multiple sclerosis in a...

Karyopharm Therapeutics NDA for Multiple Myeloma

[ Price : $8.95]

FDA accepts for priority review a Karyopharm Therapeutics NDA that is seeking accelerated approval for selinexor, an oral SINE com...