FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

AdvaMed Seeks Clarification on UDI Compliance Exceptions

[ Price : $8.95]

Advanced Medical Technology Association says FDA should clarify that a three-year compliance date exception allowed under the Uniq...

FDA Approves McGuff ANDA for Generic Delalutin

[ Price : $8.95]

FDA approves a McGuff Pharmaceuticals ANDA for hydroxyprogesterone caproate injection USP, 250 mg/mL (1.25 g/5 mL vials), a generi...

BMS Settles SEC Charges Over China Misconduct

[ Price : $8.95]

Bristol-Myers Squibb agrees to settle charges that a joint venture in China made cash payments and provided other benefits to heal...

ANDA Approval Allowed After Draft Labeling Review: FDA

[ Price : $8.95]

FDA says it will speed up generic drug approvals by allowing marketing on the basis of submitted draft, rather than final printed ...

FDA Warning Letter to St. Jude Medical

[ Price : $8.95]

FDA issues St. Jude Medical a Warning Letter citing its Atlantia, GA manufacturing facility for GMP violations related to the manu...

Comments Sought on Xenotransplantation Guideline

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on a proposed collection of information in the Public Health Service guideline on xeno...

Comments Sought on Abuse Potential of 10 Drug Substances

[ Price : $8.95]

Federal Register Notice: FDA requests comments on the abuse potential, etc. of 10 drug substances to prepare a response to the Wor...

FDA Alert on Bioprosthetic Aortic Valve Motion

[ Price : $8.95]

FDA says it has received recent reports about the reduced leaflet motion in some bioprosthetic aortic valves, including both trans...

FDA Orders Duodenoscope Postmarket Surveillance Studies

[ Price : $8.95]

FDA orders the three makers of duodenoscopes to conduct postmarket surveillance studies to better understand how the devices are r...

FTC Weighs in on Brand Drug Product Hopping

[ Price : $8.95]

An FTC brief to the Third Circuit Court of Appeals calls into question brand name drug makers product-hopping, whereby companies m...