FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Accepts Merck NDA for Fertility Drug

[ Price : $8.95]

FDA accepts for review a Merck NDA for its investigational fertility treatment, corifollitropin alfa.

Panel to Discuss Pulse Generators

[ Price : $8.95]

Federal Register Notice: FDAs Circulatory System Devices Panel will meet 10/8-9 to discuss CRT-P and CRT-D devices and a CardioMEM...

Altaire Pharma Recalls Eye Drops

[ Price : $8.95]

Altaire Pharmaceuticals recalls nine lots of carboxymethylcellulose sodium 0.5% ophthalmic solution, 30 mL, due to mold complaints...

FDA Review Documents Favor Glaxos COPD Drug

[ Price : $8.95]

FDA reviewers say clinically meaningful efficacy data have been submitted by GlaxoSmithKline to support an NDA for combination ume...

FDA Meeting with QRxPharma on Rejected Moxduo

[ Price : $8.95]

FDA schedules a 10/3 end-of-review meeting with QRxPharma to discuss the companys NDA for Moxduo, which resulted in a complete res...

Hamburg Forms Senior Group to Modify FDA Functions

[ Price : $8.95]

FDA commissioner Margaret Hamburg forms an internal Program Alignment Group (PAG) made up of senior agency staff to identify and d...

Medaus Pharmacy Recalls Sterile Drugs

[ Price : $8.95]

Medaus Pharmacy recalls certain sterile compounded consumer products due to its inability to confirm that quality control testing ...

FDA Infectious Disease Status for Cempra Antibiotic

[ Price : $8.95]

FDA issues Cempra a Qualified Infectious Disease Product designation for oral solithromycin (CEM-101), indicated for treating comm...

FDA Submits Info on Authorized Generics to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on reporting information for authorized generic drugs.

FDA Clears Kimberly-Clark Sterilization Wrap

[ Price : $8.95]

FDA clears a Kimberly-Clark 510(k) to allow use of its KimGuard One-step Sterilization Wrap with all Advanced Sterilization Produc...