FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Objectionable Conditions in Med School Pediatric Trials

[ Price : $8.95]

FDA warns Washington University pediatrics researcher Robert Hayashi about objectionable conditions in his conduct of two clinical...

AI/ML Proliferation Leading to Many Issues: Attorney

[ Price : $8.95]

Gardner Law attorney Jesse Atkins suggests ways for medical device developers and manufacturers to keep up with rapidly changing F...

FDA, Alliance Launch Lupus ABC

[ Price : $8.95]

FDA joins with the Lupus Research Alliance to launch a collaborative Lupus Accelerated Breakthrough Consortium to improve lupus cl...

Emergent Bio Gains OTC Approval of Narcan Spray

[ Price : $8.95]

FDA approves Emergent BioSolutions Narcan 4 mg naloxone hydrochloride nasal spray, the first nonprescription over-the-counter prod...

Janssen Scraps RSV Vaccine Development

[ Price : $8.95]

Janssen Pharmaceutical discontinues the development of an investigational respiratory syncytial virus adult vaccine and related Ph...

CDRH Testing Communications Info Collection

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled Testing Communications by FDAs Center for D...

FDA Shifting Accelerated Approval Approach: Attorneys

[ Price : $8.95]

Two Ropes & Gray attorneys see signs that FDA may be shifting its approach to drug accelerated approvals.

Non-Spinal Orthopedic Plate 510(k) Guidance

[ Price : $8.95]

FDA publishes a draft guidance with recommendations for 510(k) submissions for orthopedic non-spinal bone plate, screw, and washer...

Court Orders Release of FDA Vanda Info

[ Price : $8.95]

The DC federal court orders FDA to give Vanda Pharmaceuticals information from its review of a Vanda sNDA for a new Hetlioz indica...

IND Not Submitted for Cornea Associates Trials: FDA

[ Price : $8.95]

FDA warns Dallas, TX-based Cornea Associates about conducting clinical investigations without submitting a required IND.