FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Info on Communications for CVM-Regulated Products Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on testing communications on CVM-regulated products used...

Comments Sought on Dietary Supplement Guidance Info Collection

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on a guidance on substantiation for dietary supplement claims made under FDCA 403 (r)(...

Docket Set on Patient Participation in Product Discussions

[ Price : $8.95]

Federal Register Notice: FDA establishes a public docket to receive comments on agency activities performed under the patient part...

Omthera Wants NCE Exclusivity for Epanova

[ Price : $8.95]

Omthera Pharmaceuticals asks FDA to grant five-year NCE exclusivity to its naturally-derived mixture, Epanova for treating severe ...

FDA Evaluating Cancer Drugs on Pathological Complete Response

[ Price : $8.95]

FDA Office of Hematology and Oncology staffers Richard Pazdur and Tatiana Prowell say the agency has a new pathway for giving acce...

Howmedica Settles Hip Revision Surgery Claims

[ Price : $8.95]

Strykers Howmedica Osteonics unit says it has reached a settlement to resolve many lawsuits over revision surgery to replace two b...

FDA Seeks Input on Patient Involvement with Product Development

[ Price : $8.95]

FDA opens a public docket for 30 days to provide stakeholders an opportunity to submit comments on agency strategies to solicit th...

Breakthrough Therapy Designations Challenge CDER Resources: Jenkins

[ Price : $8.95]

CDER Office of New Drugs director John Jenkins says the Center has been overwhelmed with industrys response to its new Breakthroug...

Latest FDA Warning Letters

[ Price : $8.95]

In its latest batch of Warning Letters, FDA cites BioMerieux, CanineCare.us,, Elite Massagers, Health Research Laboratories, LLC/N...

Comments Sought on Animal Extralabel Drug Use

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on reporting requirements for extralabel drug use in animals.